BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORGAN PRESERVATION SOLUTION SPS

    MDR report key: 6202788 · Received December 22, 2016

    Report

    Report Number
    MW5066895
    Event Type
    Malfunction
    Date Received
    December 22, 2016
    Date of Event
    October 26, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ORGAN RECOVERY SYSTEMS
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE PT RECEIVED A DECEASED DONOR LUNG TRANSPLANT ON (B)(6) 2016. THE ABDOMINAL ORGANS OF THE DONOR WERE FLUSHED WITH A PARTICULAR ORGAN PRESERVATION SOLUTION THAT HAS SINCE BEEN RECALLED. DETAILS REGARDING THE RECALL ARE LISTED BELOW: MFR: ORGAN RECOVERY SYSTEMS (ORS) PRODUCT: ORGAN PRESERVATION SOLUTION SPS-1 LOT NUMBER: PBR-0074-330 EXPIRATION 07/01/2018 AND PBR-0060-392 EXPIRATION 06/01/2018. THE RECALL INVOLVED IN FOUL ODOR COMING FROM A CONTAINER OF SOLUTION. UPON FURTHER INVESTIGATION, IT WAS DETERMINED THAT THE TWO LOT NUMBERS MAY N=BE CONTAMINATED AND CULTURES OBTAINED DID GROW GRAM=NEGATIVE AND GRAM=POSITIVE BACTERIA, INCLUDING PANTOEA AGGLOMERANS AND ENTEROCOCCUS CASSELIFLAVUS. WE DO NOT KNOW IF THE DONOR LUNGS CAME IN CONTACT WITH THE SOLUTION. THE PT HAD RECOVERED FROM THE TRANSPLANT WITHOUT INCIDENT THUS FAR. OUR FACILITY, UNIVERSITY TRANSPLANT CENTER ((B)(6)) DOES NOT STOCK THIS PARTICULAR BRAND OF SOLUTION.) ROUTE: OTHER, THERAPY START DATE: (B)(6) 2016. THERAPY END DATE: (B)(6) 2016. ARE THE PRODUCTS COMPOUNDED? YES. DIAGNOSIS OR REASON FOR USE: ORGAN FLUSH/PRESERVATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    851486 ORGAN PRESERVATION SOLUTION SPS ORGAN PRESERVATION SOLUTION SPS KDL ORGAN RECOVERY SYSTEMS PBR-0074-330
    851487 ORGAN PRESERVATION SOLUTION SPS-1 ORGAN PRESERVATION SOLUTION SPS-1 KDL ORGAN RECOVERY SYSTEMS PBR-0060-392

    Patients

    Seq Age Sex Outcome Treatment
    1 Other