BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1961904 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00668
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 23, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF THE PATIENT DISCONNECTING AND NOT PLACING A FLEXICAP ON THE PATIENT LINE. PATIENT LINE SHOULD BE CAPPED WHEN DISCONNECTED. THERE WAS NO ALLEGATION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USER ERROR/ MIS-USE. THIS REVIEW FOUND THE LABELING ADEQUATE FOR THE USER ERROR IN THE COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE AVAILABILITY IS UNKNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A NURSE CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH WANTING TO END THERAPY WHILE USING THE HOMECHOICE DURING THE PATIENT'S THERAPY, IN DRAIN CYCLE 4 OF 6. THE PATIENT HAD DISCONNECTED HIMSELF AND DID NOT CAP OFF. THE PATIENT'S DOCTOR WAS AWARE. GTS ASSISTED THE NURSE AS REQUESTED AND REMOVED THE CASSETTE AT THE "TURN ME OFF" PROMPT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)