Recall

Baxter Healthcare Corporation has identified an issue with the software on AMIA Automated PD System cyclers which can cause shortened dwell times during a Cycle-Based therapy only. This will only occur during a Cycle-Based therapy when the Smart Drain treatment option is selected by the patient. This issue does not impact the Time-Based or Tidal therapy modes.

UMDC for Prismaflex Control Unit due to variability in the performance of the tubing in the ARPS Pump Assembly, which may lead to Code 4 (primary) TMP Too High (secondary) alarms during treatment or after a system self-test. Actions to be taken by Customers: 1) Operators may continue to use the Prismaflex according to instructions in the Operator's Manual until the tubing is replaced within the ARPS Pump Assembly. 2. If an alarm occurs, the prismaflex will default to a safe state and user should follow on-screen instructions.3. Existing pump segments can be used for critical repairs until the improved tubing is provided to your facility. 5. A local Baxter Service Rep will contact your facility to schedule the replacement of the ARPS tubing and replace affected PM and spare parts kits in your inventory.

Baxter Healthcare Corporation is issuing a voluntary Medical Device Recall for multiple
lots of 5C4482 Transfer Set (MiniCap Extended Life PD Transfer Set) listed below due
to an increase in customer complaints for no-flow and leaks under the twist clamp. The
affected lots were distributed between 6/30/2020 and 8/14/2020 in the United States. 

Smith Medical Medfusion 3500 using firmware version 6.0. Potential inappropriate bolus/loading dose delivery. If a bolus or loading dose is interrupted and a specific sequence of events occurs, inappropriate delivery (over or under-delivery of a bolus or loading dose) may occur. The following sequence may lead to inappropriate delivery: 1) Program a bolus or loading dose. 2) Initiate bolus of loading dose. 3) Interrupt the bolus or loading dose. 4) Prime the pump. 5) Resume the bolus or loading dose instead of beginning a new infusion. SOLUTION: For any reason, when a bolus or loading dose is interrupted, CANCEL the bolus or loading dose AND BEGIN A NEW INFUSION to avoid potential inappropriate delivery.

This is a warning about modifying the use of the Baxter Prismaflex and PrisMax Control Units in order to minimize exposure to COVID-19-positive patients. The actions to be taken by customers is:
"Operators can safely use the PrisMax and Prismaflex Control Units when adhering to the product-specific Operator's Manual and Graphical User Interface." and "If you distribute this product to other facilities or departments within your institution, please forward a copy of this communication to them."
The specific warnings referenced in this notice are those on pp. 1:7, 1:8, and 3:2 of the Prismaflex Operator's Manual, 7.xx, G5039912. The reply form has been submitted to Baxter by Scott Hansen.

Potential for false, "Remove USB Device 2" alarm on 2008T machines with Bluestar upgrade. If the false alarm occurs, power off the machine for 45 seconds and then power on. If the alarm occurs again, re-power cycle the machine. If problem continue pull the machine for service.  A software solution is being created. Once the software upgrade is available, an additional notification will be sent with instructions on how to order the upgrade at no charge. Technical Services will apply the software upgrade when available. 

Baxter is communicating important safety information regarding the use of connectors with the Prismaflex system. Baxter is specifying to "Always connect the return line directly to the blood access device. Do not connect additional devices between the return line and the blood access device. The use of additional devices, such as three-way valves, stopcocks, or extension lines, may impair return pressure monitoring. Their use can impede the detection of return disconnections, potentially resulting in severe blood loss." 
Tego caps qualify as an additional device between the return/access line and the blood access device (catheter).
Baxter is directing user to follow the Prismaflex Operator's Manual, 7.xx, G5039912, which lists the warnings on pages 1:8, 3:2, and 1:7. 
Actions to be taken by Customers include: 
1. Operators may continue to safely use the Prismaflex control units according to the warnings and cautions in the Prismaflex Operator's Manual.  
2. To return the customer reply form.
All serial numbers of Prismaflex Control Units are affected by this communication.

Sharesource Adequest PD kinetic modeling application contains errors in the current software version where units of measurements are not labeled correctly for the input fields in the 24-hour collection screen, the PET collection screen and the regimen results screen. Baxter will be releasing an updated software version that will correct the field mislabeling errors.  
Actions to be taken by customers: 
1. Customers may continue to safely use Sharesource Adequest software. Until the software update is performed customers may follow these calculations to ensure they are interpreting the correct information:
In the 24-Hour collection screen:
For clinics using units of mg/dl, make sure you enter Urea Nitrogen lab values into the field incorrectly labeled as "Urea (mg/dl)"
For clinics using units of mmol/L, make sure you enter serum and dialysate urea concentrations into the field incorrectly labeled as "Urea Nitrogen".
In the PET collection screen:
For clinics using units of mg/dl, make sure you enter Urea Nitrogen lab values into the input field incorrectly labeled as "Urea (mg/dl)."
In the Regimen Results screen:
Be aware that the output values incorrectly reported as "Urea removed (grams)" actually reflect "Urea Nitrogen removed (grams)."
2. Complete the enclosed Baxter Customer Reply Form and return it to Baxter.
3. If there are other facilities or departments within your institution who use this software, please forward a copy of this communication to them.

Urgent Medical Device Notice from NxStage dated 10/17/2019 outlining reports of actual UF deviations differing from machine set UF. 
Affected devices are NxStage System One (inclusive of NxStage System One S). 
The notice outlines steps for facilities and users to be aware of the UMDN, ensure pts with cardiac conditions are monitored more closely, remain aware of variables that effect weight and to weigh and calculate weight removal each treatment. Finally, when treating with higher fluid volumes, users should closely monitor patient blood pressure throughout treatment and immediately address signs and symptoms of hypertension and hypotension.

UMDC notice from Baxter dated 10/4/2019.  Baxter will be upgrading the software on Prismaflex control units to reduce the frequency of communication error alarms. All NKC Prismaflex units are effected by this UMDC notice. The actions to be taken by customers is 1. Operators may continue to safely use the Prisamflex machines until the upgrade is performed. If a communications error alarm does occur, follow the instructions presented on the graphical user interface and/or in the operator's manual. Please reinforce the importance to manually return the extracorporeal blood to the patient, and re-train users on this process, outlined on page 10.57 of the operator's manual.
2. A local Baxter service representative will contact your facility to determine the correction plan and schedule the software upgrade. The upgrade is no charge.
3. Complete the Baxter Customer Reply Form and return it to Baxter as per instruction on the form. Returning the form promptly will confirm your receipt of the UMDC notice and prevent you from receiving repeat notices.

Hach CM 130 Tubing Maintenance Assembly Kit recall supplied by Cantel (Marcor)
Hach identified an assembly error which the product may fail installation qualification.

• Baxter is issuing a voluntary recall of 1 lot of Dianeal Low Calcium with 1.5% Dextrose 2L/2L Ultrabag (CAPD) (product code 5B9766)
¿ Specific lot is: Y281477 
¿ This lot was manufactured in August 2018 and distributed between 9/6/2018 and 10/25/2018.
• Problem: Baxter Healthcare Corporation is issuing a voluntary product recall for one lot of Dianeal Low Calcium with 1.5% Dextrose 2L/2L Ultrabag (CAPD) listed below due to the potential presence of leaks on the Ultrabag tubing. Investigations identified leaks at two separate point: One on the tubing leading out of the primary container into the Y-connector and one on the tubing going from the Y-connector into the drain bag

test

test

Chantix (varenicline) 0.5mg and 1mg tablets

Levels of N-nitroso-varenicline (a potential carcinogen) above Acceptable Daily Intake levels.

Ranitidine 300mg tablet

NDMA impurity detected

Anagrelide 0.5mg capsule

Product purity out of specifications

Losartan 50mg and 100mg in 1000 count bottles

Ongoing NMBA contamination concerns

Lisinopril/HCTZ 10-12.5mg tablet

brown/black stains on tablets

Niitrofurantoin

Lot failed dissolution test

Prismaflo II and Prismaflo IIS include a Control Unit and a Heating Profiles. For the Heating Profile only and not the Control Unit, damage may result causing a hotspot on the Heating Profile. This problem only applies for those Heating Profiles produced from Dec 2015 till 2017 with serial numbers metioned in the attached document table. 
Risk of Hazard - In case a hotspot is created on a Heating profile there is a risk for the following condition to occur:
- At the location of the hotspot the Heating profile will show external damage. A hole may appear with a small burn mark.
- If the Heating Profile is in contact with the blood return line of the Prismaflex when the hotspot occurs, then the blood return line may have a burn mark on the outside surface.
- If the Heating Profile is in contact with the patient at the location of the hotspot then there is risk of a small low level skin burn. This result is extremely unlikely.
There is no risk of serious injury or death. There is no risk of fire, as the occurrence location is inside the Heating Profile. This Heating Profile damage activates a low temperature alarm at the Prismaflo IIS.
ACTIONS TO BE TAKEN BY CUSTOMERS: 
1. Operators may continue to use the Heating Profiles of the Prismaflo IIS and Prismaflo II by observing the warnings and cautions given in the user manual for the device.
2. The priority is to identify the Heating Profiles according to the serial numbers specified. These profiles must be replaced based on your accurate reply. Complete Inventory must be accounted for. For your reply use attached "Return Form" to Stihler Electronic GmbH. Send filled return form via e-mail to nicola.vosseler@stihlerelectronic.de.
3. You will receive the replacement Heating Profiles from our distributor Futuremed America, Inc., 15700 Devonshire Street, Granada Hills, 91344 California, US.

Potential for burn damage to heating profile.

Select lots of all strengths of Valsartan manufactured by Aurobindo

Aurobindo Pharma USA, Inc. is conducting a voluntary recall of 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP and Valsartan Tablets USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product.   The impurity detected in the finished drug product is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Aurobindo Pharma USA, Inc. has not received any reports of adverse events related to this recall.

Inaccurate product labeling.

The product packaging incorrectly states that the vial stoppers do not contain latex.

FA-2018-36-U
Optiflux F160NR Dialyzer (ebeam) recall dur to possibility of external blood leaks from dialyzer header. Product code 0500316E; Lots 18HU06016, 18HU06017, 18HU06018, 18HU06019. Fresenius sales rep said that NKC has not received any of the affected lots.

Fresenius states that NKC has not received any of the affected lots.

Sodium Chloride IV Solution 0.9% 150mL

Expansion of a June 2018 recall (which did not affect NKC) of certain lots of IV solutions due to the potential for flexible container leaks.

HomeChoice Integrated Automated Peritoneal Dialysis Sets with Cassettes listed below due to customer complaints received for the potential presence of leaks from the cassettes. Leaks may be present in this product lot due to an incomplete seal of the sheeting to the cassette.

Leaks from cassettes in affected lot.

Valsartan and valsartan/hctz recalled due to NDMA contamination/impurity.

This product recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), in an active pharmaceutical ingredient by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. -- in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. However, at present Prinston is unaware of any evidence that NDMA has resulted in any harm to patients taking the drugs subject to this recall.

Sodium Chloride Solution 0.45% 100mL
Sodium Chloride Solution 0.9% 100mL, 250mL
Dextrose Solution 5% 250mL

Lots: 85-023-JT, 85-033-JT, 85-018-JT, 85-031-JT, 85-016-JT, 85-021-JT, 86-001-JT 

Specific lots of Hospira IV solutions recalled due to potential for flexible container leaks, potentially related to a manufacturing issue.

2008 Hemodialysis machines

Urgent Medical Device Correction notice regarding availability of software update for 2008K2 and 2008K@HOME machines (2nd Mailing). The problem the software update corrects is when the UF Rate, Goal or Time is adjusted using the up or down arrow keys and the change is cancelled by using the "Escape" (ESC) key, the cancelled UF Rate is actually being executed rather than the Rate displayed on the machine. On January 2, 2018, Fresenius announced the availability of the Software Update for the 2008T only. This notice is for the 2008K2 and 2008K@HOME.