BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    MDR report key: 2073221 · Received April 29, 2011

    Report

    Report Number
    1423500-2011-05226
    Event Type
    Malfunction
    Date Received
    April 29, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 3, 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)

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF CONNECTION ISSUE. THE PATIENT TUGGED ON THE TUBING TO CHECK FOR A SECURE CONNECTION AND CAUSED THE TUBING TO DISCONNECT. COMPLAINT WAS NOT CONFIRMED. PER THE COMPLAINT INFORMATION, THE CAUSE OF THE COMPLAINT IS USE ERROR. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED BUT THE LOT NUMBER WAS PROVIDED. 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

    DURING FOLLOW UP ON A SEPERATE COMPLAINT ISSUE, BECAUSE A BAG FELL AND DISCONNECTED, THE HP'S WIFE HAD BEEN GIVING THE LINE A "GENTLE TUG" TO ENSURE THAT IT WAS IN PROPERLY, HOWEVER HER "GENTLE TUG" WAS TOO HARD AND SHE ACCIDENTALLY PULLED THE LINE OUT. THE HP'S WIFE SAID THAT SHE DOES NOT DO THAT ANYMORE, AND INSTEAD JUST MAKES SURE THAT THE LINE IS PUSHED IN ALL THE WAY. THE HP'S WIFE SAID THAT SHE ALSO NOTIFIED BAXTER OF THE SEPARATION. 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 H10J29072

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR HC CYCLER