BEUDAMED
    FDA Adverse Event Death Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 4091900 · Received August 20, 2014

    Report

    Report Number
    2249723-2014-01218
    Event Type
    Death
    Date Received
    August 20, 2014
    Date of Event
    July 6, 2014
    Report Date
    July 21, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, THERE IS NO INFORMATION AVAILABLE FOR THE PUMP ON WHICH THE PATIENT EXPIRED. A PUMP IS CURRENTLY BEING EVALUATED BY THE BIOMED AT (B)(6). WE ARE EXPEDITIOUSLY FOLLOWING UP WITH THE CUSTOMER FOR THE EVALUATION RESULTS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER RECEIVING ADDITIONAL INFORMATION ON THE PUMP. REFER TO THE BALLOON (B)(4) MDR # 2248146-2014-00335. INTERNAL FILE FOR THE PUMP: (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING WAS REPORTED: A PATIENT WAS TRANSPORTED FROM (B)(6) ON AN INTRA-AORTIC BALLOON PUMP (IABP). THE PATIENT WAS ON THE IABP FOR DAYS PRIOR TO THE TRANSPORT AND WAS A DNR (DO NOT RESUSCITATE). ISSUES WERE ENCOUNTERED WITH THE ARTERIAL INNER LUMEN BEING DAMPENED AND NOT BEING ABLE TO ZERO THE TRANSPORT CS300 SN# (B)(4). THE PATIENT WAS PLACED BACK ON (B)(6) PUMP AND IT WOULD ZERO AND GOT INDICES FOR A FEW MINUTES AND THE NUMBERS DISAPPEARED. THE PUMP WAS STILL PUMPING AND THE PATIENT WAS IN THERAPY, THEY JUST DID NOT HAVE A VISUAL ARTERIAL WAVEFORM. WHEN THE PATIENT GOT TO (B)(6) HOSPITAL, A PHYSICIAN REPLACED THE IAB (INTRA-AORTIC BALLOON), AND WITH THE IAB FUNCTIONING AS INTENDED. SEVERAL DAYS LATER WHEN THEY WITHDREW ALL CARE AND THERAPY, THE PATIENT EXPIRED. THE PATIENT DEATH WAS NOT ATTRIBUTED TO THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    503919 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death