BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1936008 · Received December 22, 2010

    Report

    Report Number
    1423500-2010-07152
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 2010
    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). THE SAMPLE WAS DISCARDED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON THE COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) OCCURRED DURING INITIAL DRAIN WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE LOT NUMBER IS UNKNOWN THEREFORE A BATCH REVIEW WAS NOT PERFORMED. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A PATIENT'S CAREGIVER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. THE PATIENT WAS CONNECTED AT THE TIME OF THE ERROR AND THE CAREGIVER EXPLAINED THE PATIENT WAS CONFUSED AND PRESSED "GO" IN ERROR. GTS HAD THE CAREGIVER CLOSE ALL THE CLAMPS AND CYCLE POWER TWICE TO CLEAR THE ERROR. GTS THEN ADVISED THE CAREGIVER TO DISCARD THE SETUP AND START OVER WITH NEW SUPPLIES. GTS ADVISED THE CAREGIVER TO LET THE PATIENT'S DIALYSIS NURSE KNOW OF THE ERROR. PRODUCT SURVEILLANCE CONTACTED THE PATIENT'S DIALYSIS NURSE WHO EXPLAINED THAT SHE SAW THE PATIENT AND HER DAUGHTER IN CLINIC THE DAY BEFORE, BUT NEITHER MENTIONED THE SYSTEM ERROR. THE NURSE EXPLAINED THAT THE PATIENT WAS DOING FINE AND THAT THERAPY WAS GOING WELL. 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 79 YR HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)