BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL-DISPOSABLE

    MDR report key: 1953252 · Received January 7, 2011

    Report

    Report Number
    1423500-2011-00286
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED. THE PRODUCT CODE IS UNKNOWN; THEREFORE, THE 510K NUMBER IS UNKNOWN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS COMPLAINT FOR THE SYSTEM ERROR 2240 (AIR IN LINE) WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. NOT ENOUGH DATA IS AVAILABLE WITHIN THE COMPLAINT TO IDENTIFY ROOT CAUSE; THEREFORE, THE ROOT CAUSE OF THE COMPLAINT WAS NOT DETERMINED. A BATCH REVIEW WAS NOT PERFORMED AS THE LOT INFORMATION WAS UNKNOWN. SIMILAR REPORTS HAVE BEEN RECEIVED BY BAXTER. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S GLOBAL TECHNICAL SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2240 ALARM (INDICATING AIR IN THE SET) ON THE HOMECHOICE (HC) DEVICE DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE PATIENT TO RESTART THERAPY WITH NEW SUPPLIES. THE PATIENT DISCARDED THE SUPPLIES. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL-DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE