BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS100 INTRA-AORTIC BALLOON PUMP

    MDR report key: 4095095 · Received August 18, 2014

    Report

    Report Number
    2249723-2014-01219
    Event Type
    Death
    Date Received
    August 18, 2014
    Date of Event
    July 21, 2014
    Report Date
    August 18, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K031636
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURE DEVICE HISTORY RECORD FOR THE IABP INVOLVED IN THE EVENT WAS REVIEWED. THERE ARE NO NON-CONFORMANCES RELATED TO THE REPORTED EVENT. THE COMPANY SERVICE REP OBSERVED THE REPORTED PROBLEM ON THE FAULT LOGS AND HE NOTICED THAT THE POWER SUPPLY FUSES HAD BLOWN. THE SERVICE REP REPLACED THE POWER SUPPLY/CHARGER ASSEMBLY (PART # 0014-UC-0033-05). IN AN UNRELATED REPAIR THE SAFETY DISK ASSEMBLY ((B)(4), PART # 0097-00-0985-04) WAS REPLACED AS WELL. THE IABP WAS TESTED TO FACTORY SPECIFICATION. IT FUNCTIONED NORMALLY AND WAS RETURNED TO THE CUSTOMER. IT HAS BEEN REQUESTED THAT THE REPLACED POWER SUPPLY/CHARGER ASSEMBLY (PART # 0014-UC-0033-05) IS SENT TO THE MANUFACTURING FACILITY IN (B)(4) FOR EVAL. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN NEW INFO BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER: WHEN PLUGGING IN THE INTRA-AORTIC BALLOON PUMP (IABP), A PARK WAS NOTICED. FURTHER, AFTER THE PT WAS MOVED TO THE RECOVERY WARD AND WHEN THE MEDICAL STAFF PLUGGED IN THE IABP; THE PUMP STAYED ON BATTERY MODE AND THE BATTERY CHARGING LED DID NOT INDICATE BATTERY WAS CHARGING. IT WAS ALSO REPORTED, AFTER TWO (2) HOURS, THE IABP DISPLAYED A LOW BATTERY ALARM. FOLLOWING THIS ALARM, THE CUSTOMER CALLED THE MAQUET SERVICE HOTLINE. THE MAQUET TECHNICIAN ADVISED THE CUSTOMER TO MANUALLY INFLATE AND DEFLATE THE IAB CATHETER WHILE WAITING FOR THE REPLACEMENT UNIT. WHEN THE REPLACEMENT UNIT ARRIVED, THE MEDICAL STAFF PRESENT AT THAT MOMENT WAS NOT ABLE TO REPLACE THE IAB CATHETER. THE PT DIED BUT THE CUSTOMER DID NOT LINK THE DEATH TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493120 CS100 INTRA-AORTIC BALLOON PUMP INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS100

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Death