Datascope Draws Second FDA Warning

Regulatory NewsRegulatory News | 20 February 2019 |  By 

Getinge Group subsidiary Datascope failed to adequately conduct device design validation, establish procedures for corrective and preventive actions (CAPAs) and evaluate and select potential suppliers, according to a US Food and Drug Administration (FDA) warning letter.

The warning letter was issued to the firm—acquired by Getinge in 2008—on 6 February and made public Wednesday. It marks the second warning letter to the Getinge subsidiary. The first one was issued last October to a Fairfield, NJ-based site.

The three new violations at the Mahwah, NJ plant relate to failures regarding procedures over device design validation, CAPAs and supplier selection, whereas the previous warning letter for the other site cited a lack of established processes for supplier selection, design changes and medical device reports.

The firm also failed to “develop a suitable test” for its Cardiosave intra-aortic balloon pump (IABP) to demonstrate a new top cover can protect against saline ingress, according to the new warning letter.

It further failed to demonstrate that Cardiosave devices had “passed the appropriate dielectric strength” and “leakage current tests,” as well as whether these devices “showed no signs of wetting of uninsulated electrical parts that could result in the loss of basic safety or essential performance in normal condition,” wrote Joseph Matrisciano of FDA’s Office of Medical Device and Radiological Health.

The CAPA-related violation cited a supplier welding process and welding machinery that had not been validated, and the firm’s FDA-observed failure to verify previously implemented corrective actions.

The last violation identified by the latest warning letter took issue with the firm’s failure to evaluate and select potential suppliers, contractors and consultants, citing either supplier quality agreements or supplier audits as completed well past the deadlines in the firm’s specified requirements. This comes after the 2018 warning letter identified a lack of procedures to monitor and prevent this type of issue.

In reaction to the warning letter, Swedish parent company Getinge issued a statement, explaining: “A dedicated team is working on a correction plan since an internal inspection in November 2017. Getinge has submitted an action plan, including activities and a related schedule to the FDA.” Getinge also argued that “there are no adverse events associated with serious injury or death.”

The latest warning letter, however, comes after FDA issued a letter to health care providers last November to inform of the agency’s work to evaluate more than 75 medical device reports linked to Getinge’s Maquet/Datascope IABPs related to some “shutting down while running on battery power.” The next day, the agency posted a notice that identified a Maquet Datascope/Getinge recall of the Cardiosave IABPs as a class I recall—the most serious type.

Warning letter


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