DEERFIELD, Ill., Feb. 2 /PRNewswire-FirstCall/ -- Baxter Healthcare Corporation announced today that the company’s Urgent Device Correction letter to customers dated December 13, 2005, related to the COLLEAGUE(R) Volumetric Infusion Pump, has been classified by the U.S. Food and Drug Administration (FDA) as a Class I recall. This classification does not require the return of infusion pumps currently in the market, and does not require any actions or measures by customers beyond the instructions previously provided by Baxter in its December 13 letter (see below).
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the affected product may cause serious injury or death if the problem is not corrected. The notification, which was sent to customers and posted to Baxter’s website on December 13, 2005, provided users with information related to battery undercharge, Air Detected alarm, gearbox wear, underinfusion, and undetected upstream occlusions. Baxter has received one report of a patient death that may be associated with an undercharged battery and one report of a patient death that may be associated with an interruption of therapy due to a false Air Detected alarm.
Baxter has submitted a 510(k) seeking clearance from the FDA to address the issues identified with the COLLEAGUE pump and continues to work with the Agency for successful resolution. Approximately 250,000 COLLEAGUE infusion pumps are currently in use, including 206,000 distributed in the United States. In 2005, the company established a reserve for remediation costs associated with the Colleague pump, including those identified in the December 13, 2005 customer notification. Customers with questions may contact the company at 1-800-4BAXTER (1-800-422-9837). Additional information about COLLEAGUE is available at http://www.baxter.com .
Baxter Healthcare Corporation is a subsidiary of Baxter International Inc. . Baxter International Inc., through its subsidiaries, assists healthcare professionals and their patients with the treatment of complex medical conditions, including cancer, hemophilia, immune disorders, kidney disease and trauma. The company applies its expertise in medical devices, pharmaceuticals and biotechnology to make a meaningful difference in patients’ lives.
This release includes forward-looking statements concerning the company’s pumps. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: future actions of regulatory bodies and other governmental authorities, including the FDA and foreign counterparts that could substantially affect the nature or timing of the company’s actions; additional product development steps, including software development; product quality or patient safety issues; and the other factors identified in the company’s most recent filing on Form 10-Q and other SEC filings, all of which are available on the company’s web site. The company does not undertake to update its forward-looking statements.
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Baxter Healthcare Corporation Urgent Route 120 & Wilson Road Device Round Lake, IL 60073-0490 Correction December 13, 2005 Re: COLLEAGUE VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8151 & 2M8151R; COLLEAGUE 3 VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8153 & 2M8153R; COLLEAGUE CX VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8161 & 2M8161R; COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8163 & 2M8163R Dear Director of Nursing:
Baxter Healthcare Corporation is sending this communication to notify you of an Urgent Device Correction related to the COLLEAGUE Volumetric Infusion Pump. During the investigation into resolution of issues previously communicated to customers, Baxter has identified additional issues that we want to bring to your attention. These issues fall into the following categories:
-- Battery Undercharging -- Generation of False Air Detected Alarm due to IV Administration Set Tugging -- Gearbox Wear -- Underinfusion -- Non-Detection of Upstream Occlusion
Additional information to help users avoid conditions that may interrupt therapy, along with other guidance on the usage of your COLLEAGUE pump, is described in the “Battery Usage Guide” (Attachment 1) and “Infusion Management Guide” (Attachment 2). These attachments should be provided to all users of the COLLEAGUE pump.
Battery Undercharging
Baxter has received one report of a patient death that may be associated with an undercharged battery.
Users of COLLEAGUE pumps should be aware that if the pump’s batteries are not charged continuously for 12 hours after a Battery Low alert or Battery Depleted alarm occurs, the remaining operating time after a subsequent Battery Low alert can be less than 30 minutes. This will be followed by a Battery Depleted alarm with both an audible and visual notification and the infusion(s) will stop. In order to restart the infusion(s), users must plug the pump into a power outlet immediately.
In order to avoid the possibility of interruption or cessation of therapy, loss of configuration memory, and/or device failure, it is important that you follow the charging instructions listed in the Operator’s Manual prior to using the pump under battery operation. Please also refer to the “Battery Usage Guide” (Attachment 1) for additional information on proper battery usage and maintenance.
Generation of False Air Detected Alarm due to IV Administration Set Tugging
Baxter has received one report of a patient death that may be associated with an interruption of therapy due to a false Air Detected alarm.
Pulling or tugging on the IV administration set, between the pump channel and the patient, may cause a false Air Detected alarm, which will cause the pump to stop infusing and issue an audible and visual notification. In order to reduce the potential for this situation to occur, first select an appropriate length administration set. Before loading the set into the pump, position the keyed slide clamp at an appropriate location along the administration set to ensure that there is adequate length of tubing between the patient and the pump to reduce tugging on the set during activities such as moving the patient from one bed to another, or transportation of the patient from one facility location to another.
Gearbox Wear
Baxter has identified that worn gearbox components can result in Failure Codes 812:02 and 812:05, which will result in an audible and visual alarm and the interruption of therapy. As this is associated with age and wear on the pump, older pumps are more prone to exhibit these failures. As stated in the Operator and Service Manuals, if you experience these failure codes immediately remove the pump from service and have the pump evaluated by Baxter-trained service personnel. Baxter is in the process of developing actions to address this issue and will notify you once they are finalized.
Underinfusion
Baxter has received reports of underinfusion on the COLLEAGUE Volumetric Infusion Pump. Our investigation has shown that in the presence of an obstruction during IV Administration set loading, certain pump head components can be moved out of alignment, resulting in underinfusion. The amount of underinfusion is typically 5% to 9%, but may be up to 19% below the programmed infusion rate.
To avoid an obstruction during IV administration set loading: -- Ensure that when loading the IV administration set, the tubing is loaded along the entire length of the tubing channel to avoid a misload or incomplete load situation. -- Never insert tools or other objects into the tubing channel when attempting to load or unload the administration set. -- Never use the Manual Tube Release to load or unload the administration set during normal operation.
If you suspect the accuracy of your pump may be affected, perform the Annual Operational Checkout process (which includes an accuracy test) as described in the Service Manual. If the pump fails the accuracy test, remove the pump from service and have the pump inspected by authorized service personnel following the instructions outlined in the COLLEAGUE Volumetric Infusion Pump Service Manual.
Baxter is in the process of verifying changes to the pumping mechanism to better secure these components to reduce the potential for component movement and resulting underinfusion. Baxter will notify you when these changes are available.
Non-Detection of Upstream Occlusion
As previously communicated in the attached March 17, 2005 Urgent Device Correction Buretrol letter, there is a potential for non-detection of upstream occlusion when Buretrol tubing sets are used with the Colleague Volumetric Infusion pump.
In addition to the condition described above, the following conditions should be avoided as they may result in the pump not detecting an upstream occlusion:
-- Use of a source container which has had all air removed. -- Incomplete insertion of the spike into the source container. -- Improper venting of a rigid (glass bottle) or semi-rigid (plastic) container, including Buretrols. If using rigid non-vented containers, refer to the appropriate administration set instructions to determine the correct venting procedure. -- Unopened air vent above the burette chamber during infusion.
To help ensure upstream occlusions are detected by the pump when using a Buretrol set, do not invert the set and squeeze fluid back into the primary container. Doing this may wet out the vent filter, and obstruct airflow.
Baxter will notify you when the new release of the COLLEAGUE Volumetric Infusion Pump Operator’s Manual is available. In the meantime, please immediately disseminate the attachments to all users. If you have any questions about this or any other issues regarding COLLEAGUE pumps, please contact Baxter Medication Delivery Services at 1-800-THE-PUMP (1-800-843- 7867).
Please complete the attached reply form confirming your receipt and understanding 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 the COLLEAGUE Volumetric Infusion Pump to other services or facilities, please forward this information, as it is imperative that all end users are notified and confirm receipt of this notification. Additionally, if your pump is serviced by a third party, please forward this information to the service provider.
The Food and Drug Administration has been notified of this communication. Sincerely, Robert Smith Senior Director, Quality Medication Delivery Baxter Healthcare Corporation Attachments: Attachment 1- Battery Usage Guide Attachment 2 -Infusion Management Guide Attachment 3 -March 17, 2005 Urgent Device Correction Buretrol Letter cc: Director of Biomedical Engineering COLLEAGUE VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8151 & 2M8151R; COLLEAGUE 3 VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8153 & 2M8153R; COLLEAGUE CX VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8161 & 2M8161R; COLLEAGUE 3 CX VOLUMETRIC INFUSION PUMP, PRODUCT CODES 2M8163 & 2M8163R Customer Reply Form (Urgent Device Correction letter dated December 13, 2005) Please complete and return this form to the FAX number listed below, as
confirmation that you have received this notification. A fax cover sheet is
not required. 1-847-270-5457 Facility Name and Address: Reply Confirmation Completed By: (Please print name) Title: (Please print) Telephone Number (including Area Code):
We understand the contents of the letter, performed the actions as outlined in the letter as needed, and have disseminated this information to our staff other services, facilities, customers as applicable.
Signature/Date:
REQUIRED FIELD __________________________________________________
Baxter Healthcare Corporation
CONTACT: Media, Thomas Kline, +1-847-948-2251, or Erin Gardiner,+1-847-948-4210, or Investors, Mary Kay Ladone, +1-847-948-3371, or ClareSullivan, +1-847-948-3085, all for Baxter Healthcare Corporation
Web site: http://www.baxter.com/
