BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE

    MDR report key: 2427241 · Received January 5, 2012

    Report

    Report Number
    1219856-2011-00486
    Event Type
    Malfunction
    Date Received
    January 5, 2012
    Date of Event
    December 15, 2011
    Report Date
    January 4, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 THAT THE RN STATED THE ORIGINAL PUMP WAS GIVING REPEATED PURGE FAILURE ALARMS. AS A RESULT, THE INTRA-AORTIC BALLOON PUMP (IABP) WAS SWITCHED OUT. THE RN STATED THAT THE PT IS IN AFIB, HEART RATE 85/MIN. THE CLINICAL SUPPORT SPECIALIST (CSS) EXPLAINED TO THE RN ABOUT THE DRAIN TASK AND WHY THE PURGE FAILURE ALARM OCCURRED WITH THE IRREGULAR HEART RATE. THE RN VERIFIED THAT PUMPING WAS NOT INTERRUPTED WITH DRAIN FAILURE ALARM. THE CSS STATED THAT THE RN DOES UNDERSTAND THAT THE IABP WOULD NOT HAVE TO BE CHANGED FOR THIS ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOCAT 2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON