BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RENAL-DISPOSABLE

    MDR report key: 1961835 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00658
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 15, 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 SAMPLE IS NOT AVAILABLE AND THE LOT NUMBER IS UNKNOWN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2011, BAXTER PRODUCT SURVEILLANCE SPOKE WITH THE CUSTOMER, WHO INDICATED THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT AND NO MEDICAL INTERVENTION REQUIRED. THE CUSTOMER CONFIRMED THAT THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS NOT AVAILABLE. THIS COMPLAINT WAS NOT CONFIRMED DUE TO LACK OF SAMPLE. THE CAUSE OF THIS INCIDENT WAS UNDETERMINED. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED (B)(4) SERVICE CENTER TO REPORT A SYSTEM ERROR (SE) 2367 ALARM ON THE HOMECHOICE DEVICE DURING DRAIN 3 OF 4. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE ALARM LOG AND A SE 2240 ALARM (INDICATING AIR IN THE SET) OCCURRED ON (B)(6) 2010. THE HOMEPATIENT STATED THAT THEY DISCONNECTED PRIOR TO THE ALARM AND RECONNECTED. THE TSR EXPLAINED THE ALARM AND ASSISTED WITH GETTING THE SET OUT. 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-MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE