BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2120646 · Received June 10, 2011

    Report

    Report Number
    1423500-2011-07462
    Event Type
    Malfunction
    Date Received
    June 10, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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 PRODUCT SURVEILLANCE CONTACTED THE NURSE REGARDING THE USER ERROR, AND THE NURSE STATED THE PATIENT WAS DOING FINE AND CONTINUING THERAPY WITHOUT ANY ISSUES AND WAS AWARE OF PROPER THERAPY PROCEDURES. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER WAS UNKNOWN. A LABEL REVIEW WAS PERFORMED AND FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. BAXTER 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 REPRIMED USING THE SAME SUPPLIES. (B)(4) ADVISED THE HP TO INFORM HIS NURSE (RN) THAT HE USED THE SAME SUPPLIES TO DO THERAPY. THE TSR REVIEWED PROPER PROCEDURES PER THE USER MANUAL. ON (B)(6) 2011 THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONTACTED THE RN AND ADVISED OF THIS REPORT. THE RN CONFIRMED TO FOLLOW UP WITH THE HP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 HOMECHOICE PRO