BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2822580 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04282
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    August 21, 2012
    Report Date
    August 21, 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). THIS CONDITION OF A CONNECTION ISSUE WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. THE SAMPLE WAS UNAVAILABLE AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S SERVICE CENTER REGARDING THERAPY ASSISTANCE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING SET UP. THE HOME PATIENT (HP) WAS UNABLE TO LOCATE THE PATIENT LINE. THE HP INSISTED THAT THE LINE IN THE ORGANIZER WOULD NOT CONNECT TO HIS TRANSFER SET. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED THE HP TO START OVER WITH NEW DISPOSABLES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. BAXTER PRODUCT SURVEILLANCE (BPS) CONTACTED THE REGISTERED NURSE (RN) ON (B)(4) 2012. HE STATED THAT THE PATIENT HAD NOT CONTACTED HIM ABOUT THIS INCIDENT. THE RN STATED THAT THE PATIENT'S THERAPY HAS BEEN GOING WELL, AND NO ADVERSE EVENTS WERE REPORTED. BPS SPOKE WITH THE PATIENT ON (B)(4) 2012. THE HP DID NOT RECALL THIS INCIDENT, BUT STATED THAT THERAPY HAS BEEN GOING WELL SINCE. NO ADVERSE EVENTS WERE REPORTED. ON (B)(4) 2012 GLOBAL TECHNICAL SERVICES CLARIFIED THAT THE PATIENT WAS UNABLE TO DESCRIBE THE LINE HE WAS TRYING TO CONNECT TO, NOR THE SUPPLIES HE WAS USING. THE TSR HAD THE PATIENT DISCARD THE SUPPLIES AND START OVER WITH NEW SUPPLIES IN ORDER TO ASSURE THAT THE SETUP HE USED WAS STERILE AND CORRECT.

    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 64 YR HOMECHOICE