BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT2 WAVE

    MDR report key: 3970647 · Received June 2, 2014

    Report

    Report Number
    1219856-2014-00106
    Event Type
    Malfunction
    Date Received
    June 2, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 7, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO. (B)(4). DEVICE/PARTS WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PRODUCT PREP OF AN INTRA-AORTIC BALLOON (IAB) KIT THEY WERE NOT ABLE TO ZERO THE IAB. AS A RESULT, THE PUMP WAS SWITCHED OUT. WITH THE SECOND INTRA-AORTIC BALLOON PUMP (IABP) THEY WERE ABLE TO ZERO THE IAB WITHOUT ISSUE. THE NEXT DAY, THE TECHNICAL TEAM CHANGED THE FOS ADAPTOR ON THE FIRST PUMP. THERE WAS NO REPORT OF PATIENT COMPLICATIONS. UPDATED INFORMATION RECEIVED ON (B)(6) 2014 STATED THAT THERE IS NO NEW INFORMATION AVAILABLE AND NO PARTS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321136 AUTOCAT2 WAVE INTRA-AORTIC BALLOON PUMP PRODUCTS DSP ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1