BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASTLE

    MDR report key: 256644 · Received December 23, 1999

    Report

    Report Number
    256644
    Event Type
    Injury
    Date Received
    December 23, 1999
    Date of Event
    October 19, 1999
    Report Date
    December 23, 1999
    Manufacturer
    *
    Product Code
    FLE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILIZER MALFUNCTION: BIOLOGICAL INDICATORS WERE CHECKED FOR LOADS RUN IN AUTOCLAVE. LOADS #903, 904 AND 905 SHOWED A POSITIVE BIOLOGICAL READING. PREVIOUS TO THESE CYCLES, THE BOWIE DICK TEST WAS WITHIN NORMAL PARAMETERS. RECALL PROTOCOL WAS INITIATED. 5 PTS WERE INVOLVED. ONE CASE WAS ABORTED AFTER INCISION, REQUIRING SUBSEQUENT HOSPITALIZATION/SURGICAL PROCEDURE. SECOND CASE WAS TREATED WITH ADDITIONAL LENGTH OF STAY/MEDICATION. PTS 3,4, AND 5, UNKNOWN EFFECT.

    Description of Event or Problem · 2

    STERILIZER MALFUNCTION: BIOLOGICAL INDICATORS WERE CHECKED FOR LOADS RUN IN AUTOCLAVE. LOADS #903, 904 AND 905 SHOWED A POSITIVE BIOLOGICAL READING. PREVIOUS TO THESE CYCLES, THE BOWIE DICK TEST WAS WITHIN NORMAL PARAMETERS. RECALL PROTOCOL WAS INITIATED. 5 PTS WERE INVOLVED. ONE CASE WAS ABORTED AFTER INCISION, REQUIRING SUBSEQUENT HOSPITALIZATION/SURGICAL PROCEDURE. SECOND CASE WAS TREATED WITH ADDITIONAL LENGTH OF STAY/MEDICATION. PTS 3,4, AND 5, UNKNOWN EFFECT.

    Description of Event or Problem · 3

    STERILIZER MALFUNCTION: BIOLOGICAL INDICATORS WERE CHECKED FOR LOADS RUN IN AUTOCLAVE. LOADS #903, 904 AND 905 SHOWED A POSITIVE BIOLOGICAL READING. PREVIOUS TO THESE CYCLES, THE BOWIE DICK TEST WAS WITHIN NORMAL PARAMETERS. RECALL PROTOCOL WAS INITIATED. 5 PTS WERE INVOLVED. ONE CASE WAS ABORTED AFTER INCISION, REQUIRING SUBSEQUENT HOSPITALIZATION/SURGICAL PROCEDURE. SECOND CASE WAS TREATED WITH ADDITIONAL LENGTH OF STAY/MEDICATION. PTS 3, 4 AND 5, UNKNOWN EFFECT.

    Description of Event or Problem · 4

    STERILIZER MALFUNCTION: BIOLOGICAL INDICATORS WERE CHECKED FOR LOADS RUN IN AUTOCLAVE. LOADS #903, 904 AND 905 SHOWED A POSITIVE BIOLOGICAL READING. PREVIOUS TO THESE CYCLES, THE BOWIE DICK TEST WAS WITHIN NORMAL PARAMETERS. RECALL PROTOCOL WAS INITIATED. 5 PTS WERE INVOLVED. ONE CASE WAS ABORTED AFTER INCISION, REQUIRING SUBSEQUENT HOSPITALIZATION/SURGICAL PROCEDURE. SECOND CASE WAS TREATED WITH ADDITIONAL LENGTH OF STAY/MEDICATION. PTS 3, 4 AND 5, UNKNOWN EFFECT.

    Description of Event or Problem · 5

    STERILIZER MALFUNCTION: BIOLOGICAL INDICATORS WERE CHECKED FOR LOADS RUN IN AUTOCLAVE. LOADS #903, 904 AND 905 SHOWED A POSITIVE BIOLOGICAL READING. PREVIOUS TO THESE CYCLES, THE BOWIE DICK TEST WAS WITHIN NORMAL PARAMETERS. RECALL PROTOCOL WAS INITIATED. 5 PTS WERE INVOLVED. ONE CASE WAS ABORTED AFTER INCISION, REQUIRING SUBSEQUENT HOSPITALIZATION/SURGICAL PROCEDURE. SECOND CASE WAS TREATED WITH ADDITIONAL LENGTH OF STAY/MEDICATION. PTS 3,4 AND 5, UNKNOWN EFFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE STERILIZER FLE * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization
    2 NO INFO Hospitalization
    3 NO INFO Hospitalization
    4 NO INFO Hospitalization
    5 NO INFO Hospitalization