BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1941977 · Received December 30, 2010

    Report

    Report Number
    1423500-2010-07406
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 6, 2010
    Report Date
    December 6, 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). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; HOWEVER, BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER THE PATIENT IMPROPERLY DISCONNECTED HIMSELF FROM THE HOMECHOICE AND THEN RECONNECTED. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. REVIEW OF THE LABELING REVEALS THE HOMECHOICE APD SYSTEMS AT-HOME GUIDE CONTAINS SUFFICIENT LABELING FOR THE USER ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    A CAREGIVER CONTACTED (B)(4) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING DRAIN 3 OF 6. (B)(4) EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET. THE PATIENT DISCONNECTED HIMSELF AND THEN RECONNECTED. (B)(4) ADVISED THE CAREGIVER THAT THERAPY WAS OVER AND HAD THEM CYCLE POWER TWICE TO CLEAR THE ERROR. (B)(4) THEN ADVISED THE CAREGIVER TO NOTIFY THE PATIENT'S DIALYSIS NURSE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR HOMECHOICE PRO APD CYCLER (B)(4) (REFURBISHED)