A Medical Device Daily
On the heels of a Class I recall of more than 4,000 of its Colleague line of infusion pumps (Medical Device Daily, July 20, 2007), Baxter Healthcare (Deerfield, Illinois) said the FDA has classified yet another recall of its Colleague and Flo-Gard infusion pumps as the serious, Class I variety.
Baxter said the most recent recall is voluntary and pertaining to 534 infusion pump devices in the U.S. brought in for routine maintenance or corrections at the company's Phoenix service center.
In the course of its quality control processes, the company said it discovered falsified repair, test and inspection data sheets, which included electrical safety data. Therefore, it is possible that pumps sent to be serviced, repaired or corrected were returned without service being performed on them.
The company said that three employees in the Phoenix service center "associated with" the service problem have been dismissed.
Baxter said it has recalled affected devices and has informed all customers to return the pumps for repeat inspection. All affected customers have been notified, and no serious patient injuries or deaths have been associated with the action to date, the company said. This recall action impacts only pumps distributed in the U.S.
Because of the potential risk of serious injury or patient death if affected devices malfunction, the FDA has classified the action as a Class I recall.
A defect may result in over-infusion, under-infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line, and malfunctions where the pump will stop infusing and result in an interruption of therapy.
Affected model numbers include: Flo-Gard Volumetric Infusion pump 2M8063 and 2M8064; Colleague Volumetric Infusion pump 2M8151 and 2M8153; and Colleague CX Volumetric Infusion pump 2M8161 and 2M8163.
Bear Stearns analyst Rick Wise said in a report that the company "took the issue seriously, investigated the matter, made the appropriate adjustments, and issued a Field Corrective Action with the voluntary recall."
He also noted that, according to Baxter management, the recall should have no impact on either the company's financial performance or timeline for U.S. Colleague remediation efforts. Because the recall does not require Baxter to remove product from the market, Stearns said it would likely have a minimal impact, if any, to the top line.
But news of yet another pump recall is "certainly disappointing and frustrating," Wise said, and "likely to put some pressure on company shares."
"Still, we believe the fundamental [Baxter] story of — over time — steadily improving margins, gradually accelerating EPS growth, and ultimately a higher stock price," the report said.
Earlier this week Baxter reported a Class I recall that affects 4,500 of its Colleague infusion pumps.
In a statement regarding that recall, Baxter said that it had "identified a processing anomaly related to buffer overflow that occurs in specific situations," which was implicated in "reports of 16 serious injuries that are associated with this issue at nine U.S. customer accounts."
The devices lock up when all three infusion lines are operative and a healthcare professional uses a command that creates additional demands on the user interface, such as implementing an override on dose limits. The interruption of infusion could lead to injury or death, hence the Class I recall.
The 4,500 recalled units were distributed between May 14 and June 20. Single-line pumps and upgraded triple-line pumps are not affected by the glitch and are not subject to the recall, the company said.