BEUDAMED
    FDA Adverse Event Death Summary report: N

    CS300

    MDR report key: 3142906 · Received May 30, 2013

    Report

    Report Number
    2249723-2013-00041
    Event Type
    Death
    Date Received
    May 30, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 11, 2013
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K063525
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPANY SERVICE REPRESENTATIVE EVALUATED THE IABP. HE DETERMINED THAT THE BATTERY WOULD NOT HOLD A CHARGE. THE BATTERY WAS REPLACED. THE SYSTEM WAS TESTED TO FACTORY SPECIFICATIONS AND WAS RETURNED TO THE CUSTOMER. THE BATTERY IS BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW UP MEDWATCH REPORT WILL BE SUBMITTED WHEN OUR INVESTIGATION IS COMPLETE. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE THE IABP WAS IN USE ON A PATIENT, THE PATIENT WENT INTO CARDIAC ARREST, WHEN THEY WERE CLOSING THE CHEST POST BYPASS SURGERY. THE PATIENT'S CHEST WAS RE-OPENED AND LIFE SUPPORT MEASURES COMMENCED. AFTER REESTABLISHMENT OF CARDIAC OUTPUT, THE BALLOON WAS INSERTED VIA A TRANS - THORACIC APPROACH, AS THEY WERE UNABLE TO GAIN ACCESS VIA THE FEMORAL ARTERY. THE CHEST WAS NOT CLOSED POST PROCEDURE. THE PATIENT WAS TRANSFERRED TO THE ICU, A TRIP OF APPROXIMATELY 10-15 MINUTES. UPON ARRIVAL AT THE ICU, THE IABP SHUT DOWN. IT REMAINED OFF FOR APPROXIMATELY 1 TO 2 MINUTES WHILE THE CLINICIANS PLUGGED THE IABP INTO MAINS (AC) POWER. THE IABP POWERED UP AND THERAPY WAS CONTINUED. THE PATIENT'S CONDITION CONTINUED TO WORSEN, AND THE PATIENT WENT INTO CARDIAC ARREST. ATTEMPTS TO REVIVE THE PATIENT WERE UNSUCCESSFUL. THE PATIENT EXPIRED TEN MINUTES AFTER ARRIVAL AT THE ICU. THE CUSTOMER DID NOT IDENTIFY THE LOW BATTERY ALARMS AT THE TIME OF THE EVENT, AS THIS PATIENT HAD MANY DEVICES AND MULTIPLE ALARMS OCCURRING. THE CUSTOMER HAS INDICATED THAT THEY DO NOT ATTRIBUTE THE PATIENT'S DEATH TO THE EVENT, BUT RATHER TO THEIR CRITICAL CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238199 CS300 INTRA-AORTIC BALLOON PUMP DSP DATASCOPE CORP. CS300 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death