BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES

    MDR report key: 1943025 · Received December 30, 2010

    Report

    Report Number
    6000001-2010-06466
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    July 28, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE CONDITION CANNOT BE CONFIRMED OR DUPLICATED AND THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER IS UNKNOWN.

    Description of Event or Problem · 1

    EMAIL RECEIVED IN CORPORATE MAILBOX ON (B)(6) 2010. IT WAS REPORTED BY THE NURSING STAFF THAT THERE'S NO FLOW WHEN HOOKING UP A PIGGYBACK TO THE Y-PORT WHEN USING THE CLEARLINK CONTINU-FLO SOLUTION SET, PRODUCT CODE 2H8537, LOT NUMBER UNKNOWN. THE CONDITION OCCURRED ON (B)(6) 2010 AND THE SET IS PRESENTLY IN USE ON A PATIENT AND INFUSING. THE NURSE PRIMED THE SECONDARY SET, BUT ONCE IT WAS CONNECTED TO THE UPPER Y-SITE IT WOULD NOT FLOW. TWICE MORE THE SET WAS DISCONNECTED AND THEN RECONNECTED AND IT STILL DID NOT FLOW. THE NURSE SAID THE SOLUTION BAG WAS SQUEEZED. THE STAFF WAS JUST RECENTLY TOLD TO SQUEEZE THE BAG TO INITIATE FLOW. ON THE FOURTH TRY IT STARTED TO FLOW. THIS FACILITY INFUSES CHEMOTHERAPY AND VERY RARELY ANYTHING ELSE. THE SAMPLE IS NOT AVAILABLE AS IT IS CURRENTLY INFUSING CHEMOTHERAPY. THE STAFF WAS TOLD TO HOLD ON TO SAMPLES IN THE FUTURE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL NON-DEHP CONTINU-FLO SET10 DPM, 110", 3 CL SITES SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN SECONDARY SET, UNKNOWN SOLUTION BAG