BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED PD SET WITH CASSETTE 4 PRONG

    MDR report key: 1951737 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00214
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 12, 2010
    Report Date
    December 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THE FOLLOWING INFORMATION WAS ERRONEOUSLY OMITTED IN THE INITIAL MEDWATCH. THE PATIENT COMPROMISED THE SET UP; HOWEVER, DID NOT RECONNECT. THE PATIENT CONFIRMED HE WOULD NEVER HAVE CONNECTED HIMSELF. THE PATIENT CONFIRMED THAT HE KNOWS BETTER AND WOULD CHANGE THE SET.

    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. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT THE PATIENT LINE FELL FROM THE HOME PATIENT'S (HP) HAND WHILE TRYING TO CONNECT TO THE HOMECHOICE AND FELL ON THE FLOOR. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED THE HP END SETUP. THE HP WILL START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET WITH CASSETTE 4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE PD CYCLER