FDA Warns Datascope Over QSR, Reporting Violations
The US Food and Drug Administration (FDA) sent a warning letter to New Jersey-based medical device maker Datascope Corporation over quality system regulation (QSR) and medical device reporting (MDR) violations.Datascope, which was bought by the German multinational Maquet in 2008, markets a variety of cardiovascular devices such intra-aortic balloon catheters and cardiopulmonary bypass tubing packs.
The warning letter comes after an inspection of the company's Fairfield, NJ, facility that spanned from March to June of this year.
According to FDA, Datascope's Sensation Plus 8Fr Intra- aortic balloon catheter, Mega 7.5 Fr Intra-aortic balloon catheter, Sensation Plus 7.5 Fr Intra-aortic balloon catheter, and cardiopulmonary bypass tubing packs are adulterated based on the agency's findings during the inspection.
In one instance, FDA says the company failed to adequately ensure that one of the third-party components, Circulatory Technology's Better Bladder in-line reservoir, included with its custom tubing sets met its specifications.
"The Better Bladder malfunctioned due to the seal between the small tubing with the Luer fitting (pigtail) separating from the housing allowing air to enter the housing and collapsing the balloon," FDA writes, noting that this can cause a drop in Extracorporeal membrane oxygenation (ECMO) circuit blood flow.
FDA also says that Datascope failed to validate or verify that a design change to its Sensation Plus kits did not affect the safety or effectiveness of the finished devices. FDA says the firm received multiple MDR reportable complaints detailed foreign material may have migrated to another part of the device as a result of that design change.
Additionally, FDA cites Datascope for not submitting MDRs within the 30-day window for malfunctions that may have contributed to a serious injury or death.
After reviewing the company's MDR procedure, it did not have an effective date and "does not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting."
FDA