BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1897190 · Received November 12, 2010

    Report

    Report Number
    1423500-2010-05682
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED ON THE SUSPECT LOT NUMBER(S) AND NO DEVIATIONS WERE FOUND. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE NO DEVICE EVALUATION WILL BE PERFORMED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED. THIS IS THE FIRST OF FIVE COMPLAINTS RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TREK BALLOON WAS OPENED AND INSERTED AS USUAL. ONCE THE BALLOON WAS INFLATED, IT WAS NOTED THAT THE BALLOON ONLY HAD ONE MARKER. THE SPECIFICATIONS ON THE PACKAGING WERE CHECKED AND THE DIAGRAM SHOWS TWO MARKERS ON THIS SIZE. THE COMPUTER SOFTWARE "STENT BOOST" WAS UNABLE TO BE USED AS THE BALLOON ONLY HAD ONE MARKER AND THE MACHINE WAS UNABLE TO CALIBRATED. A NON-ABBOTT DEVICE WAS USED INSTEAD. THERE WERE NO REPORTED PATIENT EFFECTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    DURING A CALL TO THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) FROM THE HOME PATIENT'S SON ON (B)(6) 2010, THE SON INDICATED THE PATIENT WAS HOSPITALIZED ON AN UNKNOWN DATE DUE TO PERITONITIS. THE FACILITY NURSE CONFIRMED THAT THE PATIENT WAS HOSPITALIZED ON AN UNKNOWN DATE IN (B)(6) 2010 FOR AN EVENT OF PERITONITIS. A CULTURE OF THE EFFLUENT WAS COMPLETED AND WAS CULTURE NEGATIVE. A CELL COUNT WAS PERFORMED HOWEVER THE RESULTS ARE UNKNOWN. A GRAM STAIN WAS PERFORMED AND WAS CULTURE NEGATIVE. THE NURSE THOUGHT THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAMS INTRAPERITONEAL (IP) FOR AN UNKNOWN LENGTH OF THERAPY. THE PATIENT OUTCOME WAS GOOD. REPORTEDLY, THE PATIENT FELL AND THE LINE DISCONNECTED RESULTING IN THE PERITONITIS. NO RETRAINING WAS NEEDED. THE NURSE INDICATED SHE DID NOT HAVE THE PATIENT'S CHART AND WAS UNABLE TO PROVIDE ANY ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R L5B4826 DIANEAL LOW CA 1.5 % 5L/5L L5B5202 DIANEAL