BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2122910 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07592
    Event Type
    Malfunction
    Date Received
    June 14, 2011
    Date of Event
    May 24, 2011
    Report Date
    May 24, 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). THIS REPORT WAS NOT CONFIRMED DUE TO LACK OF PRODUCT SAMPLE. 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 BECAUSE THE SUPPLY BAG CAME DISCONNECTED FROM THE SUPPLY LINE. THE HOME PATIENT (HP) STATED THAT WHEN SHE MOVED THE LINE TO CHECK THE SETUP, THE LINE FROM THE HEATER BAG FELL OUT; THE HEATER BAG WAS DISCONNECTED. THE HP STATED THAT THE ALARM WAS CAUSED BY HER NOT TIGHTENING THE CONNECTION SECURELY CAUSING THE BAG TO FALL. 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. THE LABELING REVIEW FOUND THE PATIENT AT HOME GUIDE TO E ADEQUATE FOR A USE/USER ERROR IDENTIFIED IN THIS INCIDENT. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR 2240 THAT OCCURRED ON THE HOMECHOICE (HC) DURING FILL 5 OF 5. THE HP STATED THAT WHEN SHE MOVED THE LINE TO CHECK THE SETUP, THE LINE FROM THE HEATER BAG FELL OUT AND DISCONNECTED THE BAG. GTS EXPLAINED THE ALARM AND REVIEWED PROPER PROCEDURES WITH THE HP PER THE USER MANUAL. BAXTER PRODUCT SURVEILLANCE FOLLOWED UP WITH THE HP WHO STATED THAT THE ALARM WAS CAUSED BY HER NOT TIGHTENING THE CONNECTION SECURELY. THE HP CONFIRMED, SHE WAS ABLE TO CONTINUE THERAPY SUCCESSFULLY WITH NO FURTHER ISSUES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR HOMECHOICE