BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOCAT 2 WAVE ITALIAN

    MDR report key: 2860008 · Received December 4, 2012

    Report

    Report Number
    1219856-2012-00342
    Event Type
    Malfunction
    Date Received
    December 4, 2012
    Date of Event
    October 26, 2012
    Report Date
    December 3, 2012
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    PMA / PMN Number
    K060309
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AWARENESS DATE OF THIS REPORT IS (B)(4) 2012. CLARIFICATION WAS RECEIVED FROM TELEFLEX (B)(4) ON (B)(4) 2012 THAT THE PUMP WAS EXCHANGED OFF OF THE PT. F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED VIA AN EQR REPORT RECEIVED ON (B)(6) 2012 BY THE COMPLAINT MANAGEMENT DEPARTMENT: PUMP WAS ON PT. HELIUM LOSS EVERY 10 MINUTES. THE WARD CHIEF DECIDED TO EXCHANGE THE INTRA-AORTIC BALLOON PUMP (IABP) PARTS REPLACED: 77-3200-001W PUMP ASSEMBLY, S/N (B)(4). ADD'L INFO RECEIVED ON (B)(6) 2012 BY TELEFLEX (B)(4) CONFIRMED THAT THE PUMP WAS EXCHANGE OFF THE PT. THE PT RECEIVED IABP THERAPY WITH THE SECOND PUMP SUCCESSFULLY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK INTRA-AORTIC BALLOON