Medical Device Daily Washington Editor

Many firms making medical equipment for providers and home use routinely purchase various components from other companies, but rarely does a company end up with a warning letter for allegedly faulty electrical cables. All the same, the Aug. 12 warning letter to Hospira (Morgan Hills, California) dealt with precisely that set of circumstances, and while Hospira did not make the cables, the fact that the manufacturer is not an FDA-regulated entity left the agency with only Hospira to target with the warning letter.

The inspection preceded a recall dated Aug. 14 announced by Hospira, which was prompted by "reports of sparking, charring and fires on the plug of the power cord," which were blamed on a propensity of the power cable to "crack and fail at or inside the plug." However, the announcement also says that Hospira "has not received any reports of serious patient harm related to the situation."

According to the warning letter, Hospira had information on at least two electrical shocks involving electrical cords supplied with the company's Plum line of infusion pumps, both of which took place in the summer of 2008. The warning letter also makes note of an undated incident in which "a user filed a report of flames discarding," presumably meaning "discharging," from one of the firm's Plum series of pumps. The flames were reported to have reached "8-12 inches in height." FDA says that Hospira notified the agency of the first two incidents via medical device reports (MDRs), but does not state whether or how the third incident was handled. FDA cited the firm in the warning letter for failure to re-evaluate the power cords after repeated incidents, purported to be required by the firm's standard operating procedure.

According to the recall notice, Hospira purchased its electrical cables from Electri-Cord (EC; Westfield, Pennsylvania), but EC's Aug. 19 statement posted at the company's web site claims that the problem is due to "abusive use exceeding" the cords' materials standard. The statement indicates that the firm's cables are subjected to an "abrupt removal" test during which "the plug is inserted into a hospital grade receptacle and a 10 pound weight is suddenly applied to the end of the cord at a 90 degree angle to the receptacle." The statement describes this test as simulating "having an employee yank on the cord improperly, without grasping the plug at the receptacle." The statement also claims, "power cord abuse has been an acknowledged problem in the hospital setting for some time."

In an unattributed statement e-mailed to Medical Device Daily, Hospira said the cords, "although meeting U.S. requirements for these types of medical plugs, could crack if misused or abused" and that the redesign of the cords "which results in a stronger, more robust cord, should minimize breakage when there is misuse." Hospira also stated that it "intends to respond fully to the FDA and is committed to addressing the observations outlined in the letter, as well as to continually improving our quality systems to ensure high standards of compliance and product integrity."

Poly Packaging warning offers no details

Some warnings provide more details than others, but the July 23 warning to Poly Packaging (Amory, Mississippi) lacked any relevant detail at all, leaving outsiders to wonder what prompted the findings.

The July 23 warning says that the April inspection disclosed that the company had "no procedures for implementing" CAPA activity, "including for example, requirements for adequately receiving and analyzing quality data to investigate and identify existing and potential causes of nonconforming product, or other quality problems." This finding was backed by the following, which states that Poly had "no procedures to receive, document, evaluate, and properly determine the disposition of complaints about the device you manufacture."

FDA also charged that the company had "no written procedures for the identification, documentation, evaluation, segregation, and disposition of non-conforming product, and that the company's management has not "ensured the quality system procedures and instructions are established and implemented, and employees are trained on such policies." FDA also noted lack of procedures for medical device reports and that the plant was not registered with FDA.

Italian firm snared in FDA warning net

FDA posted a July 2 warning letter last week addressed to Gambro Daseo (Medolla, Italy) citing the maker of tubing sets and dialysis machines for failure to validate an injection molding process, although the heavily redacted warning letter leaves little detail available. The firm had three tries to satisfy FDA's expectations on this finding, as evidenced by the agency's reference to four letters from the firm dated Feb. 27, March 27, March 30 and April 1, but was unable to ward off the finding.

However, the warning letter also alleged that Gambro failed to file an MDR in connection with a patient who passed away after dialysis. According to the warning letter, one of the company's Phoenix dialysis machines was used for a patient who subsequently was diagnosed with hemolysis, a breakdown of red blood cells, and pancytopenia, a drop in counts of both red and white blood cells. The patient was treated with antibiotics and was transfused with 6 units red blood cells, but the patient, after twelve days, "developed pulseless electrical activity with an unsuccessful resuscitation."

Mark McCarty, 703-268-5690; mark.mccarty@ahcmedia.com