company's annual meeting held at the Palmer House Hilton downtown,
Parkinson said Baxter awaits Food and Drug Administration approval of
the Deerfield-based medical products-maker's plan to fix and eventually
begin selling the pumps again. The company has been dogged by a federal
investigation into the pumps' problems.
The FDA in October
seized nearly 7,000 devices, mostly Colleague pumps, distributed from
two of Baxter's suburban facilities as part of an escalating probe of
the pumps, used primarily in hospitals to deliver medications to
A variety of issues, perhaps related to
hardware or software design, and other issues related to the Colleague
pump may be linked to seven deaths and 16 serious injuries, the company
and the FDA have said.
Baxter has not sold the pump since July of last year. The last full year of Colleague pumps generated about $170 million in sales. The Colleague has an installed base of over 200,000 pumps in the U.S., and another 40,000 mostly in Canada, Europe and Australia.
According to Baxter, "the primary issues the company is
addressing in regard to the pump are related to "design and usability"
as well as software and hardware issues involving the device's timing
mechanism." A few months ago, there was an informal survey on the Biomed Listserv asking how many hospitals had Colleague pumps with the error code that caused the initial recall. While the result was a distinct minority that found the error code, I was surprise the problem was as wide spread as it was. Having been through my share of regulatory "situations" in the past, I don't expect to see Baxter selling pumps any time soon.
There are some great folks on the pump team at Baxter and I'm sure they're doing their best to do right by their customers and their patients. Pictured right is the Colleague integrated with a Philips patient monitor, shown as an advanced development project at AACN/NTI 2005.