BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTENSION SET

    MDR report key: 3900718 · Received June 27, 2014

    Report

    Report Number
    1416980-2014-20754
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 2, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    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. HOWEVER, IT WAS REPORTED THAT THE LINES WERE NOT PRIMED PRIOR TO THE PATIENT CONNECTING AND THAT PROPER ASEPTIC TECHNIQUE WAS NOT USED WHEN DISCONNECTING. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE, WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE INSTRUCTS THE USER TO CONNECT THE PATIENT LINE EXTENSION TO THE PATIENT LINE PRIOR TO PRIMING. THE GUIDE HAS INSTRUCTIONS ON THE STEPS TO PROPERLY DISCONNECT FROM CYCLER DURING AN EMERGENCY AND EXPLAINS HOW TO RECONNECT FOR THERAPY AFTER PROPERLY DISCONNECTING. USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAREGIVER (CG) MADE A MISTAKE AND CONNECTED THE HOME PATIENT (HP) TO AN UNPRIMED PATIENT LINE FOR PERITONEAL DIALYSIS (PD) THERAPY ON THE HOMECHOICE (HC) DEVICE. DURING THE TROUBLESHOOTING FOR AN UNRELATED ALARM ON THE HC, THE CG SAW AIR IN THE LINE. THE CG STATED THAT THE PATIENT LINE EXTENSION SET WAS USED DURING THERAPY AND THAT IT WAS THAT THE EXTENSION SET WAS CONNECTED AFTER THE PRIME. THE TSR EXPLAINED THAT THE EXTENSION LINE MUST BE ADDED TO THE PATIENT LINE BEFORE THE PRIME. THE TSR ASSISTED THE CG WITH ENDING THE THERAPY, BUT THE CG DISCONNECTED THE HP WITHOUT USING ASEPTIC TECHNIQUE. THE TSR INSTRUCTED THE CG TO PUT A MINI CAP ON THE TRANSFER SET. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377503 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR HOMECHOICE, CASSETTE, TRANSFER SET, MINICAP