BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FMS ENDO 99 FMS UROLOGY PUMP

    MDR report key: 1331189 · Received February 26, 2009

    Report

    Report Number
    1221934-2009-00064
    Event Type
    Injury
    Date Received
    February 26, 2009
    Date of Event
    February 18, 2009
    Report Date
    February 19, 2009
    Manufacturer
    DEPUY MITEK
    Product Code
    KQT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MITEK IS AT THIS POINT IN TIME IN THE INFORMATION GATHERING MODE. WHEN ALL THAT CAN BE HAD, IS HAD AND THOROUGHLY INVESTIGATED AND EVALUATED, THOSE RESULTS WILL BE THE SUBJECT MATTER IN A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    A PATIENT WAS UNDERGOING A "TRANSURETHRAL RESECTION OF THE PROSTATE" (A CYSTOSCOPY) WITH THE USE OF A FMS ENDO 99 UROLOGY PUMP, A FLUID MGMT SYSTEM. THE "INFLOW" OF THE PUMP WAS SETUP TO THE PATIENT'S PENIS (?). DURING THE PROCEDURE, THE PUMP WAS ACTING ERRATICALLY. ALLEGEDLY, THE INFLOW OF GLYCERINE WAS TOO FAST, THE PRESSURE WAS 100 AND THE FLOW WAS 200, THE PUMP WOULD GO FAST, THEN SLOW, AND THEN STOP. THEY RESTARTED OR RESET THE PUMP SEVERAL TIMES (2-3 TIMES) BY PASSING OR OVERRIDING THE SAFETY STOP WITH THE SAME RESULTS. THE PATIENT WAS CONSCIOUS FOR THE PROCEDURE AND AT SOME POINT COMPLAINED OF CHEST PAIN AND DISCOMFORT AT WHICH TIME THEY STOPPED USING THE PUMP, PALPATED THE PATIENT'S ABDOMEN, AND FOUND IT TO BE ROCK HARD. THE SURGEON CONTINUED AND COMPLETED THE PROCEDURE WITHOUT USE OF THE PUMP, AND THE PATIENT WAS THEN MOVED TO THE ICU AND IS NOW IN A COMA. THERE IS A MEETING SCHEDULED AT THE FACILITY OVER THIS EVENT. THIS IS ALL THE INFORMATION THAT HAS BEEN MADE AVAILABLE TO DATE. THERE ARE GAPS IN THE DATA AND THE DETAILS OF THE EVENT; HOWEVER, THERE ARE PERTINENT QUESTIONS OUT TO OUR REPRESENTATIVE TO FILL IN THE MISSING PIECES OF THE STORY. OUR REP WILL BE SUPPLYING US WITH FURTHER DETAIL AND PROGRESS REPORTS, AS THEY ARE MADE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FMS ENDO 99 FMS UROLOGY PUMP FLUID MANAGEMENT SYSTEM KQT DEPUY MITEK UNK NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| O| R