BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACAT 1 IAB PUMP ASSEMBLY

    MDR report key: 1841918 · Received August 31, 2010

    Report

    Report Number
    1219856-2010-00589
    Event Type
    Malfunction
    Date Received
    August 31, 2010
    Date of Event
    June 19, 2009
    Report Date
    August 31, 2010
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DSP
    PMA / PMN Number
    K965209
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT HAS BEEN REPORTED THAT A ZEON 40CC INTRA-AORTIC BALLOON (IAB) WAS USED FOR THE PATIENT WITH THE ACAT 1 INTRA-AORTIC BALLOON PUMP (IABP). THE IAB VOLUME MONITOR WAS 40 CC WHEN THE PUMP WAS STARTED THE DAY PRIOR AND NOW WAS DOWN TO 30CC VOLUME. THE STAFF DISCONNECTED AND RECONNECTED THE TUBING AND THE VOLUME RETURNED TO 40CC. THERE WAS NO PATIENT DEATH OR INJURIES REPORTED. NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THE PATIENT WAS LISTED IN GOOD CONDITION WITH NO COMPLICATIONS REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ZEON INTRA-AORTIC BALLOON