BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2150536 · Received June 22, 2011

    Report

    Report Number
    1219856-2011-00214
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 20, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA A CALL REPORT AT 0011 FROM THE NURSE IN THE CVICU (CARDIOVASCULAR INTENSIVE CARE UNIT) THAT THE CONDENSATION BOTTLE HAD BEEN EMPTIED NUMEROUS TIMES AND THE ALARM WAS STILL OCCURRING EVERY 60-90 MINS. THE PT CURRENTLY IS IN SINUS RHYTHM RATE IN THE 90S. THEY ARE PLANNING TO REMOVE THE INTRA-AORTIC BALLOON (IAB) IN THE AM. IT WAS EXPLAINED BY THE CLINICAL SUPPORT SPECIALIST (CSS) THAT SHE DID NOT HAVE TO ATTEMPT TO EMPTY THE BOTTLE WITH EVERY ALARM. THE PUMP MAY NOT HAVE ENOUGH TIME TO COMPLETE THE DRAIN TASK WITH THE DIASTOLIC TIME OR A VALVE COULD BE STICKING. IT WAS EXPLAINED HOW TO PERFORM A MANUAL PURGE AND WHEN TO COMPLETE THIS TASK. SHE WAS ASKED TO CALL THE CSS BACK IF THE ALARM BEGINS TO OCCUR EVERY 20 MINS AS THE PUMP MAY NEED TO BE CHECKED OUT BY BIOMED. AT 0122AM THE SECOND CALL WAS RECEIVED WITH THE ALARM OCCURRING EVERY 20 MINS AND THE PT'S HEART RATE WAS CONSISTENTLY IN THE HIGH 80S TO LOW 90S. IT WAS SUGGESTED THAT THE INTRA-AORTIC BALLOON PUMP (IABP) BE CHANGED OUT FOR ANOTHER AND THIS BE SENT TO BIOMED SO THE VALVES COULD BE ASSESSED. THE NURSE WAS COMFORTABLE CHANGING THE IABP FOR ANOTHER. THERE WAS NO PT DEATH, INJURIES OR COMPLICATIONS. IT IS UNK IF THERAPY WAS DELAYED WHILE THE PUMP WAS EXCHANGED.

    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