BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2254276 · Received September 19, 2011

    Report

    Report Number
    1423500-2011-12390
    Event Type
    Malfunction
    Date Received
    September 19, 2011
    Date of Event
    August 29, 2011
    Report Date
    August 29, 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). THE SAMPLE WAS NOT RETURNED; THEREFORE, THE LEAK COULD NOT BE CONFIRMED AND THE CAUSE WAS UNDETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW COULD NOT BE CONDUCTED. BAXTER WILL CONTINUE TO MONITOR COMPLAINT DATA TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A FOLLOW-UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    DURING ASSISTANCE WITH STARTING OVER WITH NEW SUPPLIES ON THE HOME CHOICE (HC), THE CUSTOMER REVEALED THAT THERE WAS A LEAK SOMEWHERE WITHIN THE TUBING, AND THE SOLUTION HAD SPRAYED OUT. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP WITH STARTING OVER. DURING A FOLLOW-UP WITH THE CARE GIVER (CG) REGARDING THE REPORTED PROBLEM, THE CG STATED THAT THEY FOUND THE LEAK WITHIN THE CASSETTE DURING SETUP. THEY STATED ONCE THEY SAW THE LEAK THEY CALLED BAXTER RIGHT WAY FOR ASSISTANCE. THE PATIENT WAS NEVER CONNECTED. THEY DID START OVER WITH NEW SUPPLIES, AND THE PATIENT WAS ABLE TO CONTINUE WITH THERAPY WITHOUT FURTHER PROBLEMS. 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 62 YR HOMECHOICE