BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSFER SET

    MDR report key: 3143485 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14142
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 10, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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 HAS INSTRUCTIONS ON THE STEPS TO PROPERLY DISCONNECT FROM THE CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT TO THERAPY AFTER PROPERLY DISCONNECTING. THERE ARE DIRECTIONS TO MAINTAIN ASEPTIC TECHNIQUE WHEN FOLLOWING TROUBLESHOOTING. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HOME PATIENT (HP) HAD COMPROMISED THE TRANSFER SET WHILE USING A HOMECHOICE (HC) MACHINE. THE HP DISCONNECTED THE PATIENT LINE FROM THE TRANSFER SET, WHICH BRUSHED AGAINST HIS LEG. THE HP PUT A MINICAP ON THE TRANSFER SET TO ATTEMPT TO DISINFECT IT AND THEN RECONNECTED THE TRANSFER SET TO THE PATIENT LINE WHICH HAD NOT BEEN CAPPED. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THAT THE SUPPLIES WERE COMPROMISED AND ASSISTED THE HP IN ENDING THERAPY TO START OVER WITH NEW SUPPLIES. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED IN ASSOCIATION WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243524 TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR HOMECHOICE AUTOMATED PD SET WITH CASSETTE| HOMECHOICE, MINICAP