BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2936287 · Received January 30, 2013

    Report

    Report Number
    1416980-2013-02378
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 19, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. PER THE CUSTOMER THE SAMPLE WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, THEREFORE NO EVALUATION OR BATCH REVIEW COULD BE PERFORMED. A FOLLOW-UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE INFO AND A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT CODE IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING AIR IN THE PATIENT LINE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING DRAIN 3 OF 6. THE REGISTERED NURSE (RN) STATED THAT THE HOME PATIENT'S (HP) TRANSFER SET WAS NOT FULLY CONNECTED AND THERE WAS AIR IN THE PATIENT LINE. THE RN STATED THAT THEY HAD THE HP DISCONNECT OVER THE PHONE. THE RN WANTED TO KNOW IF THE AIR IN THE LINE SHOULD BE TREATED AS A CONTAMINATION SITUATION. THE RN STATED THAT THERE WAS NO AUDIBLE ALARM ON THE HC. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ADVISED YES. THE PATIENT WAS CONNECTED EITHER AT THE TIME OF THE ALARM OR OBSERVED AIR. THE PATIENT LINE WAS PROPERLY PRIMED BEFORE CONNECTING. PATIENT EXTENSION LINES WERE NOT USED. THE PATIENT DID NOT DISCONNECT ANY TIME PRIOR TO THE ALARM OR OBSERVED AIR. ALL BAGS WERE PROPERLY CONNECTED. THE SUPPLIES WERE NOT DAMAGED BY AN OUTLET PORT CLAMP OR AN ASSIST DEVICE USED TO MAKE THE CONNECTIONS. PROPER PROCEDURES PER THE USER MANUAL WERE REVIEWED WITH THE REPORTER. IT WAS UNKNOWN HOW THE HP WOULD COMPLETE THERAPY. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41322 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE