BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPS STATIC PRESERVATION SOLUTION

    MDR report key: 6292203 · Received February 1, 2017

    Report

    Report Number
    6292203
    Event Type
    Malfunction
    Date Received
    February 1, 2017
    Date of Event
    January 13, 2017
    Report Date
    January 20, 2017
    Manufacturer
    ORGAN RECOVERY SYSTEMS, INC.
    Product Code
    KDL
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ELDERLY GENTLEMAN WITH TREACHER COLLINS, WELL CONTROLLED (B)(6) INFECTION AND A HISTORY OF ESRD NOW STATUS POST DECEASED DONOR KIDNEY TRANSPLANTATION (THYMO INDUCTION, ON MMF/TACROLIMUS/PREDNISONE) COMPLICATED BY URINARY RETENTION, URINARY TRACT INFECTION (UTI) AND CLOSTRIDIUM DIFFICILE INFECTION. HE WAS MORE RECENTLY ADMITTED WITH ESCHERICHIA COLI (E COLI) BACTEREMIA. CT SHOWED FINDINGS POTENTIALLY CONSISTENT WITH EMPHYSEMATOUS PYELONEPHRITIS AND A 1.1CM LOW ATTENUATION NODULE ON THE PROSTATE AND PRESUMED WEDGE SPLEEN INFARCT WITH EVIDENCE OF SPLENIC GRANULOMAS AS POSSIBLE SOURCES. CT CYSTOGRAM SHOWED NO FISTULA. HE CLINICALLY IMPROVED ON CEFEPIME WITH PLANS FOR TWO FURTHER WEEKS OF LEVOFLOXACIN GIVEN THE PROSTATE ABNORMALITY AND OUTPATIENT LUMINAL GI EXPLORATION AS A SOURCE OF INFECTION. DIAGNOSIS MADE BASED ON UTI AND POSITIVE BLOOD CULTURES. URINE AND BLOOD CULTURES (1 OF 4) POSITIVE FOR E. COLI. ALSO CT SCAN PERFORMED. NOTED WHEN RECALL COMMUNICATED PREVIOUSLY: ORGAN RECOVERY SYSTEMS ("ORS") HAS ISSUED A RECALL FOR TWO ADDITIONAL LOTS OF SPS STATIC PRESERVATION SOLUTION® ("SPS"), LOT #'S PBR-0074-337 AND PBR-0060-386. (B)(6).

    Description of Event or Problem · 1

    ELDERLY GENTLEMAN WITH TREACHER COLLINS, WELL CONTROLLED (B)(6) INFECTIONS AND A HISTORY OF ESRD NOW STATUS POST DECEASED DONOR KIDNEY TRANSPLANTATION (THYMO INDUCTION, ON MMF/TACROLIMUS/PREDNISONE) COMPLICATED BY URINARY RETENTION, URINARY TRACT INFECTION (UTI) AND CLOSTRIDIUM DIFFICILE INFECTION. HE WAS MORE RECENTLY ADMITTED WITH ESCHERICHIA COLI (E COLI) BACTEREMIA. CT SHOWED FINDINGS POTENTIALLY CONSISTENT WITH EMPHYSEMATOUS PYELONEPHRITIS AND A 1.1CM LOW ATTENUATION NODULE ON THE PROSTATE AND PRESUMED WEDGE SPLEEN INFARCT WITH EVIDENCE OF SPLENIC GRANULOMAS AS POSSIBLE SOURCES. CT CYSTOGRAM SHOWED NO FISTULA. HE CLINICALLY IMPROVED ON CEFEPIME WITH PLANS FOR TWO FURTHER WEEKS OF LEVOFLOXACIN GIVEN THE PROSTATE ABNORMALITY AND OUTPATIENT LUMINAL GI EXPLORATION AS A SOURCE OF INFECTION. DIAGNOSIS MADE BASED ON UTI AND POSITIVE BLOOD CULTURES. URINE AND BLOOD CULTURES (1 OF 4) POSITIVE FOR E. COLI. ALSO CT SCAN PERFORMED (AS ABOVE). NOTED WHEN RECALL COMMUNICATED PREVIOUSLY: (B)(4) HAS ISSUED A RECALL FOR TWO ADDITIONAL LOTS OF SPS STATIC PRESERVATION SOLUTION® ("SPS"), LOT #'S PBR-0074-337 AND PBR-0060-386. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77189 SPS STATIC PRESERVATION SOLUTION SET, PERFUSION, KIDNEY, DISPOSABLE KDL ORGAN RECOVERY SYSTEMS, INC. PBR-0074-337

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other NO| NO| NO OTHER THERAPIES| NO OTHER THERAPIES