BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1984380 · Received February 10, 2011

    Report

    Report Number
    1423500-2011-01766
    Event Type
    Malfunction
    Date Received
    February 10, 2011
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR CHECK HEATER LINE ALARM WAS NOT CONFIRMED. A ROOT CAUSE WAS UNDETERMINED. A LABELING REVIEW OF THE HOMECHOICE APD SYSTEMS PATIENT AT-HOME GUIDE ISSUED WAS FOUND TO BE ADEQUATE FOR THE USE ERROR(S) IN THE COMPLAINT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK HEATER LINE ALARM THAT APPEARED ON THE HOMECHOICE (HC) DISPLAY DURING FILL 1. WHILE THE HOME PATIENT (HP) WAS EXPLAINING WHAT HE DID TO TRY TO CLEAR THE ALARM, HE DISCONNECTED THE HEATER BAG TO SEE IF SOLUTION WOULD FLOW OUT OF IT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT BY DOING THAT, THE HP HAD COMPROMISED HIS SUPPLIES AND NEEDED TO END THERAPY AND START OVER WITH NEW SUPPLIES TO MAKE SURE EVERYTHING STAYS STERILE. THE TSR THEN WALKED THE HP THROUGH THE ENDING THERAPY EARLY PROCEDURE. THE HP UNDERSTOOD EXPLANATION, ENDED THERAPY AND WOULD START OVER WITH NEW SUPPLIES. 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 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE CYCLER