BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON PUMP

    MDR report key: 4241319 · Received September 4, 2014

    Report

    Report Number
    2249723-2014-00723
    Event Type
    Malfunction
    Date Received
    September 4, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO INFORMATION HAS BEEN OBTAINED WITH RESPECT TO THE PUMP, SERIAL NUMBER, EVALUATION DATE AND RESULTS. GOOD FAITH EFFORTS WERE CONDUCTED BUT NO FURTHER INFORMATION WAS RETRIEVED FROM THE CUSTOMER. SINCE THIS FACILITY DOES NOT USE MAQUET FOR SERVICES ADN THE TIME LAPSE OF THIS COMPLAINT, NO FURTHER EVALUATION CAN BE MADE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE IABP GENERATED A "BLOOD DETECT" ALARM. THE COMPANY REPRESENTATIVE HELPED THE CUSTOMER OVER THE PHONE BY REQUESTING THEM TO CHECK THROUGHLY FOR THE BLOOD IN THE TUBING BUT NO BLOOD WAS IDENTIFIED IN THE IAB TUBING. THE CUSTOMER TURNED OFF THE PUMP AND TURNED BACK ON AFTER 10 SECONDS, AS REQUESTED BY THE COMPANY REPRESENTATIVE, BUT THE "BLOOD DETECT" ALARM PERSISTED. THE CUSTOMER WAS ADVISED TO SWITCH THE PUMP AND TAG THE ORIGINAL PUMP. THE PATIENT WAS SWITCHED TO ANOTHER IABP AND THERAPY WAS CONTINUED. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    542954 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP.

    Patients

    Seq Age Sex Outcome Treatment
    1