Additional information: e1(event site telephone: (b)(6).It was reported that the cardiosave intra-aortic balloon pump (iabp) had an issue which occurred during use, saline bag bursted into unit.A getinge field service engineer (fse) evaluated the unit end user reported burning smell and confirmed saline spill over cardiosave console.Fse replaced power management, motor control & thermal recorder pcba, cardiosave rohs power management, pcb,motor control,rohs and printer,thermal,xe-50b,custom) pcbas all contaminated.All assemblies were replaced.Device passed all calibration, performance and electrical safety tests according to factory specifications.The fse performed a full pm.The unit passed all tests and was returned to the customer for clinical use.There was a patient involvement but no harm reported.The defective components were received for further investigation.The failure analysis and testing dept.Received the following parts associated with this complaint with the failure being reported as saline damage: pn 0161-00-0024-04 rev.C, sn (b)(6) - saline damage confirmed pn 0670-00-1162, - saline damage confirmed pn 0670-00-1159, saline damage confirmed fat will not install and test these parts due to the risk associated to the cardiosave test fixture.Fat verified the saline damage on each of these parts but no root cause identified.Retaining the parts in the failure analysis and testing department per procedure number 0002-07-d008 rev.Aq.The non-conformances with the returned components were confirmed.However, the root cause or the most probable root cause is impossible to define.
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