BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 1801209 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02523
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    BAXTER HEALTHCARE ? SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. THE DEVICE INVOLVED IN THE INCIDENT WAS UNKNOWN; THEREFORE, ARE UNKNOWN. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR IS BEING SUBMITTED AS PART OF BAXTER RENAL'S RETROSPECTIVE REVIEW & REMEDIATION PROJECT. THIS REPORT IS BEING FILED TO FULFILL BAXTER'S COMMITMENT TO PERFORM A TWO YEAR RETROSPECTIVE REVIEW OF RENAL COMPLAINTS IN RESPONSE TO FDA-WARNING LETTER (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER (GTS). THE HOME PATIENT (HP) STATED SHE BELIEVED SHE HAD AIR GO INTO HER. IT WAS EXPLAINED THE HP MIGHT HAVE RECEIVED THE AIR FROM THE PATIENT LINE IF IT HAD NOT BEEN FULLY PRIMED BEFORE CONNECTING. GTS SPOKE WITH THE NURSE AS WELL AND THE NURSE WAS GOING TO HAVE THE HP COME INTO THE CLINIC. THE CAUSE WAS UNDETERMINED. THERE WAS 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 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE ? SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1