BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES

    MDR report key: 1031552 · Received April 18, 2008

    Report

    Report Number
    6000001-2008-00257
    Event Type
    Injury
    Date Received
    April 18, 2008
    Date of Event
    March 26, 2008
    Report Date
    April 8, 2008
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    FPA
    PMA / PMN Number
    K925126
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL SAMPLE WAS DISCARDED AND THE LOT NUMBERS ARE NOT AVAILABLE. COMPANION SAMPLES ARE NOT AVAILABLE SINCE LOT NUMBERS WERE NOT IDENTIFIED. SHOULD A SET BE RECEIVED FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, A SECOND BAG OF BENADRYL 50CC POSSIBLY BACKED UP INTO A 250CC BAG OF NORMAL SALINE DURING CONCOMITANT INFUSION OF RITAUXIN, RESULTING IN THE PT EXPERIENCING SYMPTOMS OF LOW BACK PAIN, FLUSHING OF THE FACE, AND FEELING "HOT" ON THE FACE. THE NURSE REPORTS, THAT THE BENADRYL APPEARED TO BE INFUSING, THEREFORE, RITUXAN THERAPY WAS STARTED. AT THAT TIME, THE PT BEGAN TO EXPERIENCE THE REPORTED SYMPTOMS. RITUXAN THERAPY WAS STOPPED AND THE REMAINDER OF 250CC OF NORMAL SALINE (PRIMARY INTRAVENOUS INFUSION), WITH THE BENADRYL, AND INFUSED. ADDITIONALLY, THE FOLLOWING INTERVENTIONS WERE ADMINISTERED: HYDROCORTISONE 100 MG INTRAVENOUS PIGGY BACK (IVPB), DEMEROL 25MG INTRAVENOUS PUSH (IVP) TIMES TWO, AND TAGAMET 300MG (IVPB). AFTER THE INTERVENTIONS, THE PT REPORTEDLY BECAME TIRED, SLEEPY AND THE REPORTED SYMPTOMS DECREASED. THE NURSE STATED, SHE SUSPECTED THAT THE BENADRYL HAD BACK FLOWED INTO THE PRIMARY BAG OF NORMAL SALINE AND THE PT HAD NOT INITIALLY RECEIVED ANY BENADRYL. THE PT HAS FULLY RECOVERED FROM THE EVENT. THE NURSE MANAGER WAS UNABLE TO CONFIRM IF THE DRIP CHAMBER WAS FULL AT THE TIME OF THE EVENT. THE NURSE MANAGER STATED, THAT NURSE DID NOT INVERT AND TAP THE CHECK VALVE PRIOR TO USE. THE NURSE MANAGER INDICATED THAT HISTORICALLY, THE NURSE DO NOT INVERT AND TAP THE CHECK VALVE AND OVER THE YEARS THE FACILITY HAS ENCOUNTERED FEW PROBLEMS RELATING TO THIS PRODUCT. THE NURSE MANAGER STATED THAT BAXTER REPRESENTATIVE HAVE VISITED THE FACILITY AND REVIEWED PREPARATION OF THE TUBING WITH THE NURSING STAFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONTINU-FLO SOLN. SET, 3 LUERACTIVATED VALVES 80FPA FPA BAXTER HEALTHCARE CORP. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention