BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2994192 · Received March 8, 2013

    Report

    Report Number
    1416980-2013-05575
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    March 2, 2013
    Report Date
    March 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS UNAVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT ARE UNKNOWN; IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE PROVIDED IN A FOLLOW-UP MDR.

    Additional Manufacturer Narrative · 1

    (B)(4).THIS COMPLAINT IS FOR A REPORT OF A SYSTEM ERROR 2240 DURING THE DWELL STAGE. THE DISPOSABLE SET WAS NOT RETURNED TO BAXTER AND THERE WAS NO REPORT OF USE ERROR OR ISSUES THAT MIGHT HAVE CAUSED THE ALARM. THE LOT NUMBER WAS NOT PROVIDED, SO NO BATCH REVIEW COULD BE PERFORMED. THEREFORE, THE ROOT CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REPORTING A SYSTEM ERROR (SE) 2240/2367 (AIR IN SET) DURING INITIAL DRAIN ON THE HOME CHOICE (HC). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) INSTRUCTED THE REGISTERED NURSE (RN) TO CYCLE THE POWER ON THE MACHINE TO CLEAR THE SE 2367, ENDING THERAPY. THE RN STATED SHE NOTICED AIR IN THE PATIENT LINE, BUT ANOTHER RN ASSISTED THE HOME PATIENT (HP) WITH CONNECTING TO THE MACHINE THAT NIGHT SO SHE WAS NOT SURE IF THE PATIENT LINE HAD BEEN PRIMED PROPERLY. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE RN THAT THE HP WOULD HAVE TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100285 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE