BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET W/CASSETTE- 4 PRONG

    MDR report key: 1231093 · Received May 23, 2007

    Report

    Report Number
    1423500-2007-00015
    Event Type
    Malfunction
    Date Received
    May 23, 2007
    Date of Event
    May 19, 2007
    Report Date
    May 19, 2007
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    A HOME PT CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REQUESTING ASSISTANCE WITH ENDING PERITONEAL DIALYSIS THERAPY ON A HOMECHOICE DEVICE. THE HOME PT STATED THAT THE PT LINE HAD BROKEN. THE HOME PATIENT SAID SHE WOULD START THERAPY OVER USING NEW SUPPLIES. THE HOME PT REPORTED THAT PRIOR TO CONNECTING HERSELF TO THE DISPOSABLE SET, SHE DID NOT NOTICE ANY CUTS, SLICES, OR HOLES IN THE TUBING AND DOES NOT KNOW WHAT COULD HAVE CAUSED THE PT LINE TO BREAK. THE HOME PT DOES NOT HAVE ANY PETS THAT COULD HAVE CONTRIBUTED TO THE ISSUE. THE HOME PT REPORTED THAT ONCE SHE CONNECTED HERSELF, SHE FELT EFFLUENT ON HER FEET AND STOPPED THERAPY IMMEDIATELY. THE HOME PT EXPLAINED THAT SHE DID NOT RECEIVE ANY ALARMS PRIOR TO CONNECTING HERSELF AND FEELING THE EFFLUENT ON HER FEET. IN ADDITION, THE HOME PT REPORTED THAT ONCE SHE STARTED THERAPY WITH NEW SUPPLIES, THE THERAPY PROGRESSED WITHOUT ANY FURTHER PROBLEMS AND SHE HAS NOT EXPERIENCED ANY FURTHER COMPLICATIONS. THE SAMPLE WAS DISCARDED BY THE HOME PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET W/CASSETTE- 4 PRONG 78FKX FKX BAXTER HEALTHCARE CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR