Medical Device Daily Washington Editor
The Nov. 22 warning letter to WalkMed Infusion (Englewood, Colorado) sheds some light on a recall announced earlier this year for the company's Triton series of pole-mounted infusion pumps, an update for which FDA announced last month. In the Nov. 24 statement, FDA indicated that the recall was triggered by reports that "the pump door open alarm does not always work on all pumps to alert the user that the pump door is open," a state of affairs that the agency said could result in free-flow perfusion, a potentially lethal state of affairs triggering the class I recall (Medical Device Daily, Nov. 30).
WalkMed is said to be refurbishing the Triton pumps, although FDA acknowledged that "no injuries have been reported to date and no reports of this issue have been received from field use." FDA's action on this product is part of a series of infusion pump recalls as part of a push toward greater patient safety, a general point of emphasis that includes a call for industry to re-examine a number of device types, including automated external defibrillators. Other firms caught up in the infusion pump action this year are Sigma (Medina, New York) and Baxter Healthcare (Deerfield, Illinois).
The issue with the Triton pump doors arose in the warning letter in connection with a multi-point citation for design controls. FDA states in the warning letter that a failure to include administration sets in the design verification/validation for the Triton led the risk analysis to draw the conclusion "that over-infusions would always be detected when in fact the failure of the door open alarm resulted in over infusions, causing [the] firm to conduct a product recall."
This group of citations also includes the finding that the company's design controls included "no inputs for the WalkMed infusion administration sets, which are to be used with the infusion pumps." Another of the downstream consequences of this omission, according to FDA, was that the procedure "failed to identify and evaluate potential hazards involved with use of the administration sets, such as, sub-component and connector failures and non-sterility."
Beyond those matters, the warning letter also cites the firm for failure to "revise the ... risk analysis, document [redacted] after receiving at least [redacted] complaints of severe under-infusion when patients were using the pumps at home."
FDA states that the firm's Sept. 30 response to these inspectional findings (the inspection concluded Sept. 16) indicated that the company had revised its design and risk assessment documents and would "conduct user testing," but WalkMed apparently did not "provide the revised documents for ... evaluation," and FDA seemed discontented with the proposed term for completion of user testing, the date of which was redacted.
Some of these issues migrated to the firm's complaint-handling procedures. The warning letter led with a citation for failure to conduct investigations into complaints of "severe under-delivery of infusion fluid," to determine whether the event was reportable as a medical device report (MDR). A second part of this series of citations notes that the company's complaint questionnaire "was missing pertinent information," although the warning letter offers no specifics, clarifying only that WalkMed made "no attempt ... to obtain this information" in pursuit of an assessment of the potential for patient injury.
The firm's response to this finding is said to have included a proposal to rewrite the procedures, but FDA states that WalkMed included none of the new procedures in its response, hence the agency found the response inadequate.
The warning letter addresses the recall of the pole-mounted Triton units, said to have been initiated on June 17, but FDA states, "we wish to remind you that reports of corrections or removals of this type are to be submitted ... within 10 days." The firm's response to this finding was also seen as inadequate because WalkMed "did not provide a copy" of an updated field action and recall procedure.
The warning letter also makes note of an MDR filed in September for an event that took place in January, and the agency reminded WalkMed that such reports are to be filed with 30 calendar days.
The company did not respond to a call for comment.
Abbott announces recall of glucose test strips
Abbott Diabetes Care (Alameda, California) has announced a recall of more than 350 million glucose test strips marketed under the Precision, MediSense, and Optimum brand names.
According to Abbott's Dec. 22 statement, the strips "may give falsely low blood glucose results, which can lead users to try to raise their blood glucose when it is unnecessary and to fail to treat elevated blood glucose due to a falsely low reading." The problem, Abbott states, is apparently connected to "longer than expected blood fill times," a characteristic that may "be dependent on the age of the strips and [whether] the strips have been stored in (or exposed to) higher temperatures" higher than 72 Fahrenheit "for an extended period of time."
Abbott advises customers to discontinue use of the strips, although anyone who is unable to replace the strips in a timely fashion can use the strips so long as they track the time needed for blood to saturate the strips. The firm advises that any saturations needing longer than five seconds disqualifies the results. The statement notes that one bad strip does not necessarily mean that all the strips in the package are affected.
According to FDA's Dec. 22 statement on the recall – which, like Abbott's statement does not explain what gave rise to the higher saturation times – the recall may lead to market shortages in strips sold to healthcare providers, hence FDA is asking providers to use alternate means of testing glucose levels in their patients. The recall is not expected to affect availability of strips sold to patients for their personal use.
Fresenius Kabi alert upgraded to recall
FDA also announced last week an update to a recall by Fresenius Kabi (Bad Hamburg, Germany) for red blood cell exchange sets used in the company's AS104 blood cell separation devices. According to FDA, the recall, initiated as a safety alert on Oct. 18, is a class I recall for lots manufactured from October 1, 2007 to July 30, 2010. The agency instructs users to return the units to the company's U.S. subsidiary, located in Redmond, Washington. The action was prompted by reports that the devices, used for depletion or exchange of RBCs during apheresis procedures, have removed "greater amounts of red blood cells than intended, resulting in hemodilution."
Mark McCarty, 703-268-5690;