It was reported that post patient care the cardiosave intra-aortic balloon pump (iabp) failed the pim leak test.There was no patient involvement, and no adverse event reported.There was no patient involvement and no patient harm reported.A getinge field service engineer fse was dispatched to the site to evaluate the unit.He states that cathlab personnel identified unit as failing the pim leak test, post patient care.Cathlab turned over unit to biomed for resolution.Successfully completed a simulated treatment with testing catheter and trainer without issue upon initially testing the unit.Unit however failed the all manifold, pim section, 4th test, thus pointing to the safety disk membrane.The all manifold test however, successfully completed, other than the aforementioned.Replaced suspect safety disk and successfully completed an all manifold test without issue.Unit calibrated and passed all functional and safety tests per factory specifications.Returned to customer and cleared for clinical use.The nrc verified the failure of the safety disk failure of the membrane differential pressure with the results of 7 mmhg.Factory specification is +/- 6mmhg.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to be defined.
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