BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4233796 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39204
    Event Type
    Malfunction
    Date Received
    November 6, 2014
    Date of Event
    October 11, 2014
    Report Date
    October 12, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED AND A CAUSE OF THE DISCONNECTION COULD NOT BE DETERMINED. IT WAS ALSO REPORTED THAT THE PATIENT MADE A MISTAKE BY RECONNECTING AFTER A SPONTANEOUS DISCONNECTION. PROPER USER INSTRUCTIONS ARE ADDRESSED IN ¿THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE¿ WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE INSTRUCTS THE USER NOT TO ATTEMPT TO REUSE ANY DISPOSABLE SUPPLIES. IT ALSO WARNS THE USER THAT POSSIBLE CONTAMINATION OF THE FLUID OR FLUID PATHWAYS CAN RESULT IF DISPOSABLES ARE REUSED. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S TRANSFER SET GOT SEPARATED FROM THE PATIENT LINE AND THE PATIENT ENDED UP RECONNECTING IT. THE PATIENT STATED THAT IT HAPPENED FOR A MOMENT, AT SOME POINT DURING THE THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE ADVISED THE PATIENT TO START OVER WITH ALL NEW SUPPLIES AND EXPLAINED WHY. THE PATIENT UNDERSTOOD AND WAS ASSISTED WITH ENDING THE THERAPY IN ORDER TO START OVER WITH NEW SUPPLIES. DURING THE FOLLOW UP WITH THE CARE GIVER REGARDING THE REPORTED EVENT, THEY EXPLAINED THAT THE PATIENT HAD CONNECTED AND WENT TO LIE DOWN. THEN, THEY NOTICED THAT THE PATIENT LINE HAD DISCONNECTED FROM THE TRANSFER SET. THE PATIENT RECONNECTED AND WENT TO SLEEP FOR A FEW HOURS AFTER WHICH THEY CONTACTED BAXTER¿S TECHNICAL SERVICES FOR ASSISTANCE. THE TRANSFER SET HAS SINCE BEEN REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    715807 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR HOMECHOICE, AUTOMATED PD SET WITH CASSETTE