BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1160485 · Received September 12, 2008

    Report

    Report Number
    1423500-2008-00794
    Event Type
    Injury
    Date Received
    September 12, 2008
    Date of Event
    August 26, 2008
    Report Date
    August 26, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REGARDING A 2240 ALARM THAT OCCURRED ON THE HOME CHOICE (HC) DURING PATIENT USE. THE NIGHT OF THE EVENT, THE PARENTS REPORTEDLY HEARD THE DEVICE ALARM DURING THERAPY AND FOUND THE TRANSFER SET DISCONNECTED FROM THE PATIENT WITH FLUID ON THE FLOOR. THE CAREGIVER STATED THE HOME PATIENT (HP) WAS SLEEPING WHEN THE TRANSFER SET CAME OFF THE CATHETER. THE TSR HAD THE CAREGIVER CLOSE ALL CLAMPS AND CYCLE THE POWER OFF/ON, AND 2367 ALARM WAS RECEIVED. THE CAREGIVER WAS ADVISED TO END THERAPY AND CONTACT THE CLINIC IN MORNING REGARDING MISSED THERAPY RECOMMENDATIONS. THE PARENTS TOOK THE PATIENT TO THE EMERGENCY DEPARTMENT WHERE HE WAS STARTED ON KEFLEX ORALLY (UNKNOWN DOSE). THE PATIENT WAS SEEN AT THE DIALYSIS CLINIC THE FOLLOWING DAY AND THE TRANSFER SET WAS REPLACED. THE NURSE SAID, THE HP'S EXIT SITE WAS DIRTY, SWEATY, SWOLLEN, AND RED IN COLOR. A CULTURE OF THE FLUID AND THE CATHETER EXIT SITE WERE TAKEN. BOTH CULTURES GREW STAPHYLOCOCCUS WAMERI. THE HP HAD NO PAIN AND HIS TEMPERATURE WAS NOT ELEVATED. THE PATIENT WAS GIVEN A LOADING DOSE OF 250MG ANCEF INTRA-PERITONEAL (IP) AND THEN PRESCRIBED ANCEF 750MG IP Q DAY THROUGH 2008. THE NURSE STATED THE HP HAD BEEN PLAYING WITH THE CATHETER, EARLIER ON THE DAY OF THE EVENT, THE HP WAS WRESTLING WITH HIS BROTHER IN THE DIRT WHEN THE CATHETER DRESSINGS CAME OFF. THE NURSE STATED THE TRANSFER SET HAD NO SIGNS OF A DEFECT AND IN HER OPINION THE HP HAD LOOSENED IT FROM WRESTLING AND PLAYING WITH IT. THE PARENTS STATED THAT ALL BAGS HAD CLEAR FLUID. THE PATIENT WAS SEEN AT THE CLINIC ON EIGHT DAYS EARLIER, AND THE EXIT SITE WAS CLEANED AND DRESSED. THE SITE WAS NOTED TO BE WITHOUT REDNESS OR DRAINAGE AT THIS TIME. RIFAMPIN 800 MG BID ORALLY WAS ORDERED FOR NINE DAYS. THE PATIENT IS SCHEDULED FOR A CLINIC VISIT ON THREE DAYS LATER, AND THE TRANSFER SET WILL BE CHANGED AGAIN AT THIS TIME. A REPEAT CULTURE WILL BE TAKEN ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG 78FKX FKX BAXTER HEALTHCARE UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 7 YR Required Intervention