The production device history record (dhr) for this iabp unit was reviewed and no non-conformances related to the reported event were noted.A company service representative was dispatched to evaluate the unit and was unable to reproduce any malfunction.The representative found no evidence of blood contamination in the unit or any other problems.The representative performed all functional, calibration and electrical safety tests per factory specifications, and unit was returned to customer for clinical use.
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On 1/20/2017, the customer initially reported that during use on a patient, blood was noted in the maquet balloon catheter.Subsequently, the patient was transferred to another facility, the balloon replaced and the patient placed on another pump.The customer then asked that the device be checked out to ensure that no malfunction of the pump had occurred.No adverse event was reported to us at this time.On 2/15/2017, we received medwatch #mw5067576 in which the customer reported that the patient sustained a serious injury on (b)(6) 2017 as a result of this event.Consequently, we contacted the customer to obtain information on this serious injury claim and on 2/17/2017, the customer reported the following additional information: the patient underwent left heart catheter complicated by dissection to mid-lad.Stent placement followed and balloon pump was placed for support and dopamine was started.Patient went to ccu with iabp 1:1, dopamine, propofol and intubated.Overnight lost augmentation and blood was noted in the iabp tubing.Furthermore, an additional report is being submitted with the information regarding the intra-aortic balloon (under (b)(4)).
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