BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2102982 · Received May 25, 2011

    Report

    Report Number
    1423500-2011-06476
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ANY FURTHER INFORMATION BECOME AVAILABLE, A FOLLOW UP WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER CONTACTED THE NURSE REGARDING THE USE ERROR. THE NURSE STATED THAT SHE WAS NOT AWARE OF THIS ISSUE. THE NURSE STATED THAT THE PATIENT IS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUES. THE NURSE WOULD REVIEW PROPER PROCEDURES WITH THE PATIENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED. THIS COMPLAINT FOR A USER ERROR WAS CONFIRMED. THE CAUSE WAS DETERMINED TO BE THE PATIENT DISCONNECTED AND RECONNECTED USING THE SAME SUPPLIES. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR A RELATED REPORT, THE HOME PATIENT (HP) STATED HE HAD DISCONNECTED BUT STARTED OVER WITH THE SAME SUPPLIES. THE HP STATED HE WAS ON A FISHING TRIP. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE HP NOT TO USE THE SAME SUPPLIES AS THEY WERE COMPROMISED. THE TSR ADVISED THE HP TO START OVER WITH NEW SUPPLIES AND CALL BACK FOR FURTHER TROUBLESHOOTING IF NECESSARY. THERE WAS PATIENT INVOLVEMENT BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR HOMECHOICE