BEUDAMED
    FDA Adverse Event Death Summary report: N

    IAB: 8 FR - 40 CC

    MDR report key: 1884985 · Received October 22, 2010

    Report

    Report Number
    1219856-2010-00753
    Event Type
    Death
    Date Received
    October 22, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 21, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K981660
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AT 0035 EST, THE INTRA-AORTIC BALLOON PUMP (IABP) WAS ALARMING HELIUM LOSS 2 ALARMS. THE PERFUSIONIST PHONED THE CLINICAL SUPPORT SPECIALIST (CSS) TO TROUBLESHOOT THE HELIUM LOSS ALARMS. THE PT IS TACHYCARDIC WITH HEART RATES RANGING FROM LOW 100'S TO 140'S SINUS. THE PERFUSIONIST ALREADY SWITCHED PUMPS, TRIED ANOTHER SET OF HELIUM DRIVE TUBING AND ALSO DECREASED THE VOLUME TO 37CC. THE CARDIOLOGIST IS AT BEDSIDE VERIFYING PLACEMENT AND DOES NOT WANT TO REMOVE THE INTRA-AORTIC BALLOON (IAB). THERE IS NO BLOOD NOTED IN THE HELIUM DRIVE TUBING AND NO VISUAL KINKS. THE PERFUSIONIST IS GOING TO DECREASE VOLUME FURTHER AND ATTEMPT OTHER TROUBLESHOOTING MEASURES. THE CSS GAVE THE PERFUSIONIST HER DIRECT CELL NUMBER TO CALL WITH AN UPDATE; CSS RECEIVED NO FURTHER CALLS. AT 1341 EST, THE CSS PHONE ACCOUNT AND SPOKE TO THE CHARGE RN. PER THE CHARGE RN, THEY ARE STILL RECEIVING ALARMS AND IAB VOLUME IS DOWN TO 35 CC. THEY ARE ALSO IN A 1:4 RATIO. ALARMS ARE OCCURRING APPROX EVERY 3 MINUTES. THE CSS RELAYED THAT THIS SEEMS TO BE A RUPTURED IAB. THE CARDIOLOGIST IS AWARE OF THE FREQUENCY OF ALARMS AND DOES NOT WANT TO REMOVE IAB. THE CSS PAGED THE PERFUSIONIST, BUT RECEIVED NO RETURN CALL. AT 1444 EST, THE CSS CALLED THE CHARGE RN AGAIN AND RN STATED THAT "THEY ARE CALLING IN THE FAMILY TO DISCUSS WITHDRAWING SUPPORT ON THE PT." THE CSS CONFIRMED WITH THE CHARGE RN THAT "THIS MEETING WITH THE FAMILY WAS NOT DUE TO THE IAB AND RN CONFIRMED THAT IT WAS NOT IAB/IABP RELATED." (PT'S CONDITION DETERIORATED UNRELATED TO THE IABP PER THE RN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IAB: 8 FR - 40 CC INTRA-AORTIC BALLOON PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death INTRA-AORTIC BALLOON PUMP