BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETROGRADE CARDIOPLEGIA CANNULA

    MDR report key: 2587360 · Received May 22, 2012

    Report

    Report Number
    2028837-2012-00001
    Event Type
    Malfunction
    Date Received
    May 22, 2012
    Date of Event
    May 16, 2012
    Report Date
    May 22, 2012
    Manufacturer
    CALIFORNIA MEDICAL LABORATORIES, INC.
    Product Code
    DWF
    PMA / PMN Number
    K010974
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY: DEVICE WAS RETURNED IN A PLASTIC BAG. PENDING DECONTAMINATION, DEVICE WAS EVALUATED BY VISUAL INSPECTION. ALL COMPONENTS WERE DETERMINED TO BE PRESENT. THE TUBING CLAMP WAS IN THE CLAMPED POSITION. ADDITIONALLY, DEVICE WAS RETURNED WITH SYRINGE ATTACHED. SYRINGE WAS MANIPULATED WITHIN THE PLASTIC BAG TO TEST THE THREE LUMENS. THE MAIN CANNULA TUBING AND PRESSURE MONITORING LINE WERE PATENT. THE PINHOLE LEAK IN THE BALLOON WAS VERIFIED, AS AIR WAS ADDED BUT THE BALLOON DID NOT INFLATE, AND DROPS OF LIQUID INSIDE THE BAG WERE DISTURBED BY THE ESCAPING AIR. NO OTHER DAMAGE TO THE DEVICE COULD BE IDENTIFIED.

    Description of Event or Problem · 1

    PIN HOLE LEAK; THAT IS, THE CUFF BEGAN TO DEFLATE AFTER INFLATING DURING CLINICAL APPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RETROGRADE CARDIOPLEGIA CANNULA RETROGRADE CARDIOPLEGIA CANNULA DWF CALIFORNIA MEDICAL LABORATORIES, INC. RCM-14115 S112343

    Patients

    Seq Age Sex Outcome Treatment
    1 Other