It was reported that a getinge field service engineer (fse) ordered two helium regulators for stock for cardiosave intra-aortic balloon pump (iabp), and upon receipt, it was clear from the packaging that one of the regulators was used.There was no malfunction of the iabp unit reported.There was no patient involvement, and no adverse event reported.
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Updated fields: b4, d9, e1(site country), g3, g6, h2, h3, h4, h6(type of investigation, investigation findings, investigation conclusions), h10.It was reported that a getinge field service engineer (fse) ordered two helium regulators for stock for cardiosave intra-aortic balloon pump (iabp), and upon receipt, it was clear from the packaging that one of the regulators was used.There was no malfunction of the iabp unit reported.There was no patient involvement, and no adverse event reported.The defective components were received for further investigation.Please refer to the root cause evaluation field for details.In order to reproduce the failure, the suspect high pressure helium regulator was installed in the cardiosave test fixture.The following test was performed - leak test (sniffer) (seq.(b)(6)).Results : pass.The non-conformances with the returned components were not confirmed.However, the root cause or the most probable root cause is not confirmed.
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