BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPS-1

    MDR report key: 6199788 · Received December 22, 2016

    Report

    Report Number
    MW5066871
    Event Type
    Injury
    Date Received
    December 22, 2016
    Date of Event
    November 17, 2016
    Report Date
    December 22, 2016
    Manufacturer
    ORGAN RECOVERY SYSTEMS
    Product Code
    KDL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    PT HAD A RENAL TRANSPLANT ON (B)(6) 2016. PT PRESENTED TO THE ED ON (B)(6) 2016, FROM AN OUTSIDE HOSPITAL WITH CT SHOWING RETROPERITONEAL HEMATOMA. PT UNDERWENT SURGERY TO CORRECT AN APPARENT BLEED FROM THE ILIAC ARTERY ANASTOMOSIS. THIS RESULTED IN THE LOSS OF THE TRANSPLANT ALLOGRAFT. CULTURE OF THE ILIAC ARTERY AT THE TIME OF SURGERY GREW 4 PLUS PSEUDOMONAS AERUGINOSA. WE WERE NOTIFIED BY (B)(6) ON (B)(6) 2016 THAT THE PT'S TRANSPLANTED ORGAN HAD BEEN PERFUSED WITH SPS-1 SOLUTION LOT # PBR-0074-330 EXPIRATION 07/01/2018 AND/OR LOT # PBR-0060-392 EXPIRATION 06/01/2018. THERAPY START DATE: (B)(6) 2016. USED TO PRESERVE OR PERFUSE AN ORGAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    848311 SPS-1 STATIC PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0074-330
    848312 SPS-1 STATIC PRESERVATION SOLUTION KDL ORGAN RECOVERY SYSTEMS PBR-0060-392

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| O