BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 1133081 · Received August 22, 2008

    Report

    Report Number
    1219856-2008-00401
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CLINICAL SUPPORT WAS NOTIFIED OF A CALL FROM THE CATH LAB AT THE HOSPITAL. CLINICAL SUPPORT IMMEDIATELY CALLED AND SPOKE WITH THE CLINICIAN. THE CLINICIAN STATED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) MALFUNCTIONED REQUIRING THE PUMP TO BE REMOVED FROM THE PT. DETAILS SURROUNDING THE EVENT INDICATE THAT THE PUMP WAS PUMPING FINE, THEN STOPPED PUMPING. THE PUMP INDICATED "SYSTEM FAILURE 6 AND FRONT END MALFUNCTION". THE PUMP WAS POWERED DOWN AND THEN BACK UP; PUMP STARTED PUMPING, BUT THE ALARMS OCCURRED AGAIN. THE CLINICIAN STATED THAT THE PUMP WAS DISCONTINUED FROM THE PT AS THEY DID NOT HAVE ANOTHER PUMP AVAILABLE; TWO OTHER PTS WERE CURRENTLY ON PUMPS. THE PT WAS DOING FINE WITHOUT THE BALLOON PUMP THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK