BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1970007 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-00988
    Event Type
    Malfunction
    Date Received
    January 25, 2011
    Date of Event
    January 4, 2011
    Report Date
    January 4, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FROM A NURSE WHO HAD THE PATIENT CONNECTOR LOWER THAN THE HEATER BAG. THE ROOT CAUSE OF THIS CONDITION IS ATTRIBUTED TO USER ERROR. THE COMPLAINT WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. 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.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH FLUID COMING OUT OF THE TOP OF THE PATIENT LINE WHILE USING THE HOMECHOICE (HC) DURING PRIMING. THE PATIENT WANTED TO KNOW IF THIS WAS OK DURING PRIMING. GTS EXPLAINED THAT THE TOP IS VENTED AND THAT FLUID WILL SOMETIMES LEAK OUT. PRODUCT SURVEILLANCE CONTACTED THE PATIENT WHO EXPLAINED HE FORGOT TO RAISE THE PATIENT LINE FOUR INCHES WHEN HE REMOVED THE CLAMP DURING PRIMING. THERAPY HAD BEEN GOING WELL SINCE THE INCIDENT. 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 77 YR HOMECHOICE PRO APD CYCLER (B)(4) (REFURBISHED)