BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG

    MDR report key: 670789 · Received January 26, 2006

    Report

    Report Number
    1423500-2006-00168
    Event Type
    Malfunction
    Date Received
    January 26, 2006
    Date of Event
    January 4, 2006
    Report Date
    January 4, 2006
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    HOME PATIENT'S (HP) SPOUSE CALLED IN TO BAXTER'S TECHNICAL SERVICE CENTER AND REQUESTED ASSISTANCE WITH RE-PRIMING THE PATIENT LINE USING THE HOMECHOICE SYSTEM. HP INADVERTENTLY LEFT CLAMP CLOSED ON PATIENT LINE. TECHNICAL SERVICE REP (TSR) INSTRUCTED HP TO OPEN PATIENT LINE AND THEN ASSISTED WITH RE-PRIMING THE PATIENT LINE TO CONNECT YOURSELF/CHECK PATIENT LINE PROMPT. HP VERIFIED PATIENT LINE IS FULL WITH FLUID AND NO AIR BUBBLES OBSERVED. NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED AT THE TIME OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE INTEGRATED APD SET WITH CASSETTE 3-PRONG HOMECHOICE CASSETTE FKX BAXTER HEALTHCARE CORPORATION NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN