Letter Condemning Delayed Recall of Defective Intravenous Infusion Pumps
Frank Torti, M.D., M.P.H.
Acting Commissioner, Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Dear Dr. Torti,
Once again, the FDA’s Center for Device Evaluation and Radiological Health (CDRH) has failed to accept its legal responsibility to protect the public health, in this instance by dangerously delaying requesting a recall of defective intravenous infusion pumps that the manufacturer has admitted “may lead to serious injury and/or death.”[1]
On January 23 of this year, Baxter wrote to users of its infusion pumps about serious problems that can lead to an interruption of therapy.[1] The letter did not ask for a recall of the defective devices. Instead, it provided instructions for addressing the malfunction with defective devices. If such a malfunction occurs, it says the pump should be replaced with another one and the incident should be reported to Baxter. Yesterday, Baxter warned that these failures “have been [associated with] serious injuries and/or deaths.”[2]
The first Class I recall of these devices was on July 19, 2005, and was due to pumps shutting down without warning.[3] At this time, the company acknowledged six serious injuries and three deaths were associated with the device. Since then, there have been six additional recalls including the one announced yesterday. The recalls and the reasons for the recall are listed in table below.
Amazingly, because of problems such as battery failures, false alarms and alarm failures, and inadequate infusion, Baxter has not sold the pumps in the U.S. since 2005, according to The Chicago Tribune.[4] But pumps continue to be used for patients in this country.
Why did it take the FDA until March 11th, nearly seven weeks, to decide that this problem was serious enough to merit being classified as a Class I recall, that is, one in which the FDA states “there is a reasonable probability that use of the product will cause serious injury or death”?[5]
Furthermore, why in the face of six previous Class I recalls of these devices including at least 16 additional deaths[6] and many additional serious injuries since the first recall, is the FDA so belatedly asking Baxter to recall the devices again? Why has the company thus far announced that hospitals should continue to use the devices and discontinue use only if a malfunction occurs?
In summary, why has the FDA not used its authority for mandatory device recalls to remove these devices which have a long history of serious, life-threatening problems from health care facilities where they continue to be used?
We hope for a prompt response to these urgent questions.
Sincerely,
Sidney M. Wolfe, M.D.
Director
Jonas Hines
Researcher
Health Research Group at Public Citizen
Class I recalls of Baxter COLLEAGUE infusion pumps
|
Date |
Reason |
URL |
|
July 19, 2005 |
Spontaneous shut-down |
|
|
September 19, 2005 |
Battery defect causing excessive discharge |
|
|
December 13, 2005 |
Battery undercharging, false alarms, under-infusion, fail to detect occlusion, gearbox wear causing spontaneous shut-down |
|
|
June 20, 2007 |
Spontaneous stopping of infusion |
|
|
June 21, 2007 |
Repair, inspection, and test data sheets were falsified |
|
|
August 15, 2007 |
Service technician did not perform all of the hardware upgrades related to recalls |
|
|
January 23, 2009* |
Software and battery usage failures (*Letter of notification by Baxter on 1/23 but declared Class I by the FDA on 3/11/09) |
[1] Baxter. Urgent device correction; COLLEAGUE Volumetric Infusion Pump Mono 2M8151 and 2M8153, CX 2M8161 and 2M8163, and CXE 2M9161 and 2M9163. January 23, 2009. www.baxter.com/about_baxter/news_room/downloads/1-23-09_Final_US_Letter_…. Accessed March 12, 2009. Now available at: https://www.citizen.org/sites/default/files/1-23-09_final_us_letter_2.pdf.
[2] Baxter. FDA classifies recent urgent device correction on Baxter´s Colleague Infusion Pump as a Class I recall. March 11, 2009. http://www.baxter.com/press_room/press_releases/2009/03_11_09_colleague.html. Accessed March 12, 2009.
[3] Food and Drug Administration. FDA Announces Class I recall of Baxter Healthcare’s Colleague Volumetric Infusion Pumps. July 21, 2005. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108464.htm. Accessed March 12, 2009.
[4] Miller JP. Baxter’s Colleague infusion pump under FDA’s most serious recall. The Chicago Tribune. March 11, 2009. www.chicagotribune.com/business/chi-biz-baxter-colleague-infusion- pump-march11,0,4595929.story. Accessed March 12, 2009.
[5] Food and Drug Administration. Class 1 Recall: Baxter Colleague Single and Triple Channel Volumetric Infusion Pumps. March 11, 2009. www.fda.gov/cdrh/recalls/recall-012309.html. Accessed March 12, 2009.
[6] Food and Drug Administration. Search MAUDE database. Updated February 28, 2009. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm. Accessed March 12, 2009.