BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFADEX + THAM SOLUTION

    MDR report key: 7650347 · Received June 29, 2018

    Report

    Report Number
    3007710603-2018-00001
    Event Type
    Malfunction
    Date Received
    June 29, 2018
    Date of Event
    May 30, 2018
    Report Date
    June 22, 2018
    Manufacturer
    XVIVO PERFUSION AB
    Product Code
    KDN
    UDI-DI
    07350069520067
    PMA / PMN Number
    K091989
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT WAS NOT AN ADVERSE EVENT NOR WAS THE PRODUCT MALFUNCTIONING. THE DEVICE WAS DAMAGED DURING USE. [CUSTOMER MEDWATCH REPORT MW5077650.PDF].

    Description of Event or Problem · 1

    THIS INFORMATION WAS PROVIDED BY THE CUSTOMER TO THE FDA IN A VOLUNTARY MEDWATCH REPORT (MW5077650) DATED (B)(6) 2018. "PHYSICIANS AND PROCUREMENT STAFF WERE INVOLVED IN A LUNG RECOVERY. THE PERFADEX PRESERVATION SOLUTION WAS TRANSPORTED TO THE FACILITY IN A COOLER. ONE BAG OF SOLUTION WAS INFUSED DURING THE RECOVERY AND A SECOND BAG WAS PREPPED FOR INFUSION AFTER THE LUNGS WERE RECOVERED. AFTER APPROXIMATELY HALF OF THE FLUID WAS INFUSED FROM THE SECOND BAG, A SMALL HOLE WAS DISCOVERED IN THE TOP PORTION OF THE BAG. THE RECOVERY SURGEONS WERE INFORMED ABOUT THE INCIDENT AS WELL AS THE TRANSPLANTING SURGEON AND THE DECISION WAS MADE TO CONTINUE WITH THE PROCEDURE. THE HOLE WAS VERY SMALL AND ONLY A SMALL STREAM OF FLUID LEAKED FROM THE BAG WHEN PRESSURE WAS APPLIED. A REPORT WAS FILED WITH THE (B)(4). MFR (XVIVO PERFUSION) HAS BEEN CONTACTED (AND RESPONDED QUICKLY) AS WELL. ALTHOUGH THE MANUFACTURER DENIED ANY CURRENT RECALL NOTICES (I HAD ALSO VERIFIED RECALLS ON THE FDA SITE), THEY DID STATE THAT AS OF 2018, THEY HAVE A NEW BAG DESIGN THAT WILL HOPEFULLY ELIMINATE FUTURE INCIDENTS. WE WILL CONTINUE TO MONITOR THE PATIENT CLOSELY. AT PRESENT, THE PATIENT IS RECOVERING WITHOUT INCIDENT. SUSPECT: YES; PRIMARY: YES; PRODUCT TYPE: DRUG/BIOLOGIC. DOSE OR AMOUNT: 2800 ML, FREQUENCY: 1 TIME, ROUTE: INTRAVENOUS. STRENGTH: NA ML. THERAPY DURATION: 20 YEARS. REASON FOR USE: LUNG PRESERVATION DURING ORGAN RECOVERY." XVIVO PERFUSION HAS DETERMINED THAT NO MDR IS REQUIRED AS THIS DEVICE WAS DAMAGED DURING PROCEDURE BY APPLYING PRESSURE TO THE BAG AND THERE WERE NO SERIOUS EVENT RELATED TO THIS. HOWEVER WE WANTED TO ACKNOWLEDGE THE RECEIPT OF THE MEDWATCH REPORT FROM THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492215 PERFADEX + THAM SOLUTION COLD PRESERVATION SOLUTION KDN XVIVO PERFUSION AB 19018 600148 07350069520067

    Patients

    Seq Age Sex Outcome Treatment
    1