BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 2182145 · Received July 28, 2011

    Report

    Report Number
    1423500-2011-09883
    Event Type
    Malfunction
    Date Received
    July 28, 2011
    Date of Event
    January 24, 2011
    Report Date
    January 24, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL HOMECHOICE DEVICE WAS EVALUATED FOR THE REPORTED CONDITION: THE DEVICE OVERPRIMING THE PATIENT LINE WAS NOT CONFIRMED AND NOT DUPLICATED. THE ROOT CAUSE OF THE REPORTED CONDITION WAS NOT DETERMINED. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A HOMECHOICE (HC) OVERPRIME ISSUE (DURING PRIMING, THE PATIENT WAS NOT CONNECTED). THE NURSE STATED THAT THE UNIT KEPT OVERPRIMING THE PATIENT LINE. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) ARRANGED FOR A SWAP OF THE UNIT DUE TO THIS ISSUE. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1