BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 2195058 · Received July 20, 2011

    Report

    Report Number
    1219856-2011-00261
    Event Type
    Malfunction
    Date Received
    July 20, 2011
    Date of Event
    July 7, 2011
    Report Date
    July 15, 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
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED PER FIELD SERVICE REPORT: PUMP WAS ON PT. SYMPTOM - REPORTED "FOS OUT OF RANGE" MESSAGE. NURSE WAS UNABLE TO ZERO THE INTRA-AORTIC BALLOON (IAB). THE NURSE STATED TO BIOMED THAT SHE WAS ABLE TO ZERO HER FOS (FIBEROPTIX SENSOR) TEST FIXTURE, BUT HAD TROUBLE SLIDING IT INTO FOS SLIDE CONNECTOR. FINDINGS/ACTION TAKEN: WAS UNABLE TO DUPLICATE THE COMPLAINT OF "UNABLE TO ZERO IAB" BUT HAD TROUBLE INSERTING FOS TEST FIXTURE INTO THE FOS SLIDE CONNECTOR. REPLACED FOS SLIDE CONNECTOR. CONFIRMED FOS TEST FIXTURE INSERTED SMOOTHLY INTO THE NEW FOS SLIDE CONNECTOR. UNIT PASSED FUNCTIONAL CHECKOUT. ADD'L INFO RECEIVED FROM BIOMED ON (B)(6) 2011 STATED THAT THEY DID NOT WANT TO GO MANUALLY SINCE THE PT WAS IN CARDIAC ARREST ALREADY. AS A RESULT, THEY SWITCHED OUT THE PUMP FOR ANOTHER PUMP WITH SUCCESS. THERAPY WAS ABLE TO CONTINUE AND THE PT MADE IT THROUGH THE EVENT SUCCESSFULLY. THE PUMP IS BACK IN SERVICE.

    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 INTRA-AORTIC BALLOON