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Health Canada Endorsed Important Safety Information on the Market Removal of Baxter/Sabratek 6060 Infusion Pumps

Nov 21, 2005 | Health Canada

Re: Market Removal of Baxter/Sabratek 6060 Infusion Pumps

Dear Director of Nursing:

Baxter Corporation is sending this communication to provide you with important safety information concerning the 6060 Infusion Pump. Baxter has received reports of failures within the PCA profile as well as reports of incidents that result in interruptions of therapy in various profiles. Details are outlined in the Reported Problems sections below. Due to the technological limitations of this product and the obsolescence of certain critical components, Baxter will be working with customers to conduct a controlled removal of all 6060 Infusion Pumps from the market. As the timing of this removal will depend upon your ability to evaluate and implement a substitute device, Baxter will coordinate with customers individually to ensure a smooth transition. We will continue to produce sets and provide service during the transition period.

During this period of product removal Baxter is advising you to:

* Discontinue the use of the PCA profile to avoid a potential overinfusion or non-delivery condition. While the probability of occurrence of the PCA profile delivery failures is rare, patients should be converted to another delivery profile or device.

* Immediately discontinue the use of the pump for therapies where interruption of the infusion could cause immediate patient harm.

Failure to follow the above instructions could result in an unsafe situation for the patient.

To help explain all of the current instructions relative to this and previous field corrective actions, a chart of the pump’s profiles and the associated instructions is included with this notification as Attachment 1. This attachment should be distributed to all users of the pump.
Reported Problems:

PCA Profile Delivery: The PCA mode should not be used, and should be disabled on all 6060 Infusion Pumps.

* Event Log Discrepancies: Baxter has received one death and two serious injuries reports that may be associated with potential over infusions within the PCA profile. In each case, the event histories indicated that the device failed to return to the basal rate following a bolus request, but also indicated that the bolus volume was not delivered. Despite exhaustive internal and external investigations, Baxter has been unable to replicate these types of failures.

* Unrequested Bolus Dose: Baxter has identified that a frayed PCA cord or fluid ingress into the device may create an intermittent short of the PCA circuit and simulate the repeated pressing of the PCA button. As a result, bolus doses may be delivered (within the programmed prescription limits) without the patient initiating the request.

* Undelivered PCA Bolus Requests: Baxter has received reports where the pump will not deliver requested PCA boluses while in the TOTAL MEDS ALLOWED mode.

Interruption of Therapy

* Non-Delivery Without Indication: Baxter has received reports where the infusion unexpectedly stops without an alarm or malfunction code. This has been observed in the Auto-Ramp and 25-Period profiles.

* Unwarranted Alarms: Baxter’s investigation into the occurrence of some malfunction alarms has identified that the pump may incorrectly generate an alarm condition even if an error is not present. The most commonly seen malfunction alarms include Malfunction 7, 9, 20, 25, and 26 codes.

Product Removal

Baxter will be working with customers over the next twelve (12) months to conduct a controlled removal of all 6060 Infusion Pumps from the market. However, due to the quantity of pumps in the field, we recognize it may take customers time to safely replace their existing 6060 pumps with alternatives. During this transition period, Baxter will continue to provide service and sets for the 6060 pump. Your Baxter Sales Representative will contact your facility within the next week to discuss alternatives and help coordinate the return of the 6060 pumps to Baxter.

Please complete the attached reply form confirming your receipt of this letter and fax it back to Baxter at the number provided on the form. Returning the form promptly will prevent you from receiving a repeat notice. If you provide 6060 pumps to other services or facilities, please forward this information. It is imperative that all end users of the 6060 pumps be notified.

We apologize for any inconvenience this may cause you and your staff. We are committed to helping you work safely through this difficult situation. If you have questions regarding this communication, please call The Center for One Baxter at 1-800-422-9837.

Health Canada has been notified of this action.


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