Warning Letter – Datascope purchasing controls

Datascope Corporation
Product: drug manufacturing facility
Date:9/11/18

Purchasing controls; complaint investigations 1. Failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, as required by 21 CFR 820.50(a). Specifically, your firm performed a supplier assessment from (b)(4) for Circulatory Technology and approved (“(b)(4)”) the use of your supplier’s Better Bladder with your Custom Tubing Sets on (b)(4), which are used as part of an extracorporeal membrane oxygenation cardiopulmonary bypass circuits. However, complaint 148267 was submitted as a MDR on October 17, 2017 for an event that occurred with the Better Bladder on September 26, 2017 where the product failed to meet specifications (“product in the field was released as nonconforming to established 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. The collapse of the balloon can increase resistance to flow in the venous line and causes a drop in ECMO circuit blood flow. Your firm’s failure to implement adequate purchasing controls has resulted in the expansion of the Better Bladder recall by your supplier, during the month of March of 2018, to include more lots of product after you received complaints related to device failure.

FDA District: CDRH

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