FDA warns Getinge’s Datascope over IABP production facility issues

The FDA this week released a warning letter it sent to Getinge‘s (PINK:GETI B) Datascope over issues it found during an inspection of its Fairfield, N.J.-based facilities used to manufacture intra-aortic balloon catheters.

During the inspection, which took place between March 19 and June 11 this year, the FDA said that it identified five different instances in which the facilities were out of conformity with its requirements.

In its first point, the federal watchdog said that Datascope failed to establish and maintain quality requirements with its suppliers, specifically noting one such failure with the supplier of a “Better Bladder” and custom tubing sets. The agency noted a total of four complaints related to the bladder and tubing sets filed in relation to the supplier.

The FDA said that the company had already responded to the issue, but that its response “is not adequate and does not address the above violation.”

In its second noted violation, the FDA said that the company failed to identify, document and validate design changes related to its Sensation Plus IABP kits. The agency said that certain Sensation Plus IABPs were shipped to customers in June, July and August last year which had “foreign matter on the pouch” of the insertion kits.

The FDA said that the company had responded, but that it was seeking an update on the status of the corrective action.

The agency also knocked the company for two instances of failing to submit an MDR report to the FDA less than 30 days after it received notification that one of its devices may have caused or contributed to a death or serious injury.

The federal watchdog said that the company received a complaint that suggested that its IABP and accessories may have caused or contributed to a patient death as a result of a malfunction. The FDA said that the company received notice of the event on June 11, 2015, and did not submit the report until September 10, 2015. The agency also noted a similar report the company received on September 19, 2017, but didn’t file until November 13, 2017.

The agency said that while it received a response, the company did not “provide evidence of those planned corrections and corrective actions with the response to the FDA.”

In its last point, the FDA said that the company failed to develop, maintain and implement written MDR procedures as is required, and that it saw no evidence it implemented an MDR procedure or internal systems necessary to determine if reports meet necessary criteria. The agency also noted that the company did not describe how it plans to address documentation and record-keeping requirements related to MDRs.

The agency gave the firm 15 business days to respond to the noted violations, according to the published warning letter.

In June, the FDA slapped a Class I label on a select recall of Getinge’s Datascope and Maquet Cardiosave hybrid intra-aortic balloon pumps over issues related to fluid seepage and corrosion.

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