BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2230369 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11507
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 14, 2011
    Report Date
    August 14, 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). 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT WAS FOR A CONNECTION ISSUE AND WAS CONFIRMED BASED ON INFORMATION PROVIDED BY THE HOME PATIENT (HP) STATING THAT THEY DID NOT CONNECT THEIR FINAL BAG ALL THE WAY AND SOME OF THE FLUID LEAKED OUT. THE LABEL REVIEW FOUND THE PATIENT AT HOME GUIDE TO BE ADEQUATE FOR THE USE ERROR IN THIS INCIDENT. 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.

    Description of Event or Problem · 1

    DURING ASSISTANCE WITH SET UP ON THE HOME CHOICE (HC), DURING USE; THE PATIENT REVEALED THEY HAD CONNECTED THE BAGS INCORRECTLY. THEY STATED ONE OF THE BAGS WAS NOT CONNECTED SECURELY AND SOME OF THE FLUID STARTED TO LEAK OUT. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE PATIENT WITH STARTING OVER. DURING A FOLLOW-UP WITH THE HOME PATIENT (HP) REGARDING THE REPORTED PROBLEM, THE HP STATED THAT THEY DID START OVER WITH NEW SUPPLIES, AND DOUBLE CHECKED THE CONNECTION. THE HP STATED THERAPY WENT FINE AFTERWARDS, AND HAS BEEN GOING FINE SINCE. THERE WAS PATIENT INVOLVEMENT BUT 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 HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR HOMECHOICE