FDA warn’s Getinge’s Datascope about ongoing IABP issues

The FDA recently revealed a warning letter it sent to  Getinge‘s (PINK:GETI B) Datascope over ongoing issues uncovered during an inspection of its Mahwah, N.J.-based intra-aortic balloon pump production facilities last year, noting a number of continuing quality and validation issues that have not yet been appropriately managed.

The federal watchdog said that it has received responses to the originally noted violations, but noted several issues in which the responses did not adequately address.

In its first noted violation, the FDA dinged the company for a failing to perform design validation that includes production unit testing in actual or simulated use conditions.

The agency said that Datascope failed to develop a suitable test method for its Cardiosave IABP to “demonstrate the assembly of the new top cover protects against saline ingress in order to ensure only safe and effective devices are produced,” according to the warning letter. The FDA added that it also failed to show that the Cardiosave devices “passed the appropriate dielectric strength, leakage current tests, and whether it showed no signs of wetting of uninsulated electrical parts that could result in the loss of basic safety or essential performance in normal condition.”

The federal watchdog said that it received a response on the matter, but that it “did not address” the specific violations. The agency also noted that Datascope failed to evaluate user needs and intended use to mitigate potential hazards, and that no documentation was provided to show that it passed appropriate electric strength and current leakage tests.

In its second noted violate, the FDA knocked the company for failing to establish and maintain corrective and preventive action procedures, including unvalidated welding processes performed by a supplier and batteries which failed to meet the minimum run time in the company’s CS100, CS100i and CS300 IABP devices.

The FDA said that it has received a response from Datascope, but that neither response successfully addressed the violations.

In its last noted violation, the agency said that the company failed to evaluate and select suppliers, contractors and consultants on their ability to meet quality requirements. The FDA said that the company only investigated seven suppliers, and did not determine “if additional suppliers were made acceptable.”

The agency gave the company 15 business days to respond to the letter, and proposed a regulatory meeting “to discuss this recent inspection.”

Last November, the agency posted a letter to healthcare providers warning of reports that Getinge’s Datascope and Maquet intra-aortic balloon pumps are shutting down while running on battery power, which could result in serious injury or death.

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