BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2831553 · Received November 14, 2012

    Report

    Report Number
    1416980-2012-05074
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 8, 2012
    Report Date
    October 9, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE IS UNKNOWN. THIS COMPLAINT IS NOT CONFIRMED AND THE CAUSE WAS NOT IDENTIFIED BECAUSE THERE WAS NO SAMPLE RETURNED TO BAXTER FOR EVALUATION. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE. NO ADVERSE TREND WAS IDENTIFIED FOR THIS MECHANISM. THE ROOT CAUSE WAS UNDETERMINED.

    Description of Event or Problem · 1

    A CARE GIVER (CG) CONTACTED GLOBAL TECHNICAL SERVICE (GTS) REPORTING A SYSTEM ERROR 2240 ALARM (AIR IN SET) ON THE HOME CHOICE (HC) DURING INITIAL DRAIN. THE CG STATED THAT THERE WAS AIR BUBBLES IN THE PATIENT LINE. THE CG INSPECTED AND STATED THAT THERE WAS A LEAK THAT APPEARS TO BE IN THE HOME PATIENT (HP) CATHETER AT THE EXIT SIDE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE CG TO CONTACT THE RN URGENTLY REGARDING THE CATHETER ISSUE. ON (B)(4) 2012, PRODUCT SURVEILLANCE CONTACTED THE REGISTERED NURSE (RN) REGARDING THE REPORTED EVENT. THE RN STATED THAT IT WAS NOT THE CATHETER WITH THE HOLE, BUT IT WAS THE TRANSFER SET. IT HAS BEEN CHANGED AND THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 1 CASSETTE