BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1113166 · Received August 12, 2008

    Report

    Report Number
    1423500-2008-00741
    Event Type
    Injury
    Date Received
    August 12, 2008
    Date of Event
    July 26, 2008
    Report Date
    August 1, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS DISCARDED.

    Description of Event or Problem · 1

    IN 2008, THE HOME PT'S SPOUSE CONTACTED A BAXTER TECHNICAL SVC REP (TSR) REGARDING A SYSTEM ERROR 2240 (AIR IN LINE) ALARM THAT APPEARED ON THE DISPLAY OF THE HOME PT'S HOMECHOICE MACHINE DURING DWELL 4/5 OF THEIR AUTOMATED PERITONEAL DIALYSIS THERAPY. THE HOME PT (HP) LEFT A CLAMP OPEN ON THE UNUSED SUPPLY LINE CAUSING THE ERROR. THE TSR HAD THE HP CYCLE POWER TO CLEAR THE ERROR AND DISCONNECT USING ASEPTIC TECHNIQUE. THE TSR ADVISED THE HP TO CONTACT THE PERITONEAL DIALYSIS NURSE REGARDING MISSED THERAPY. NO PT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT. ON THE FOLLOWING MONTH, A F/U CALL TO THE PERITONEAL DIALYSIS NURSE INDICATED SHE WAS AWARE OF THE 2240 ALARM. THE NURSE STATED THAT THE PT IS FINE BUT WAS DIAGNOSED WITH PERITONITIS ON ORIGINAL MONTH. THE PT HAD ABDOMINAL PAIN AND WAS ADMITTED TO THE ER BRIEFLY AND WAS DISCHARGED THE SAME DAY AFTER BEING GIVEN A LOADING DOSE OF ANTIBIOTICS (TYPE UNSPECIFIED). THE NURSE BELIEVES THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION AS THE PT CULTURED POSITIVE FOR STAPHYLOCCOCUS EPIDERMIS. THE PT TOLD THE NURSE HE HAD "GOTTEN SLOPPY" WITH HIS THERAPY. THE PT WAS RETRAINED ON PROPER PROCEDURE. THE PT HAS SINCE RECOVERED FROM THE PERITONITIS. FURTHER INFO WAS NOT AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R