BEUDAMED
    FDA Adverse Event Summary report: N

    EXACTAMIX NON-VENTED HIGH-VOLUME INLET

    MDR report key: 3832221 · Received September 3, 2013

    Report

    Report Number
    1419106-2013-00005
    Date Received
    September 3, 2013
    Date of Event
    August 5, 2013
    Report Date
    August 20, 2013
    Manufacturer
    BAXTER HEALTHCARE CORP
    Product Code
    LHI
    PMA / PMN Number
    K002705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IN SPEAKING WITH THE OPERATOR, WE LEARNED THAT THE DIFFICULTY SHE IS EXPERIENCING OCCURS ONLY WITH THE BAXTER HEALTHCARE PRE-FILLED BAGS (SWFI AND DEXTROSE 70 PERCENT) AND SHE REQUESTED ADVICE ON HOW BEST TO SPIKE THESE LARGER BAGS WITH MORE ROBUST PORTS. OUR TECHNICAL SUPPORT STAFF STRESSED THE IMPORTANCE OF PROPER SPIKING TECHNIQUE. PROPER TECHNIQUE INCLUDES FIRST HANGING THE BAG ON THE HOOD HANGER, AND THEN TURNING THE BAG WITH ITS SPIKE PORT FACING DOWN. THEN, INSERT THE SPIKE, ROTATING THE SPIKE 180 DEGREES, AS SHOWN ON PAGE 48 OF THE ATTACHED USER MANUAL. THE OPERATOR WAS INSTRUCTED TO CONTACT US IF THERE WAS ANY CHANGE IN HER CONDITION. ON (B)(4) 2013, A FOLLOW-UP CALL WAS PLACED TO THE OPERATOR IN REGARDS TO HER CONDITION. WE LEARNED THAT HER ARM WAS STILL SORE, AND SHE HAD YET TO SEEK AN EVALUATION WITH OCCUPATIONAL THERAPY. ON (B)(4) 2013, ANOTHER CALL WAS PLACED TO ASCERTAIN HER CONDITION. SHE STATED THAT SHE HAS NOT STARTED PHYSICAL THERAPY AT THIS TIME. ON (B)(4) 2013, WE LEARNED THAT THE OPERATOR WAS OUT OF THE PHARMACY AND WOULD NOT BE IN UNTIL THE FOLLOWING WEEK. ON (B)(4) 2013, AN EMAIL WAS SENT TO THE OPERATOR REQUESTING AN UPDATE ON HER STATUS, AND AGAIN ASKING HER TO INFORM US OF ANY CHANGES TO HER CONDITION. WE WILL PERFORM IN-HOUSE PRODUCT TESTING IN AN EFFORT TO REPLICATE THE REPORTED ISSUE. A FOLLOW-UP TO MDR 1419106-2013-00005 WILL BE SUBMITTED ONCE THIS TESTING HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THIS IS NOT A PT ADVERSE EVENT, BUT AN OPERATOR INJURY. ON (B)(6) 2013, WE BECAME AWARE OF AN INCIDENT WHERE A DEVICE OPERATOR COMPLAINED OF DIFFICULTY SPIKING BAXTER HEALTHCARE PRE-FILLED BAGS (SWFI AND DEXTROSE 70 PERCENT) WITH THE USE OF OUR EXACTAMIX NON-VENTED HIGH VOLUME INLET, PART NUMBER H938173. THE OPERATOR CLAIMS THAT THE SPIKING IS CAUSING SORENESS IN HER ARM, WITH PAIN BEGINNING TO MOVE UP TO HER NECK. IT SHOULD BE NOTED THAT PHARMACY TECHNICIANS COMPOUND THERAPY BAGS IN HIGH VOLUMES; THEREFORE, DUE TO HIGH-VOLUME REPETITIVE WRIST/ARM ACTIVITIES, TECHNICIANS ARE PRONE TO WRIST/ARM INJURIES. THE OPERATOR STATES THAT SHE WILL BE SEEKING TREATMENT THROUGH OCCUPATIONAL THERAPY. THESE ISSUES ARE BEING INVESTIGATED BY BAXTER HEALTHCARE CORPORATE PRODUCT SURVEILLANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437144 EXACTAMIX NON-VENTED HIGH-VOLUME INLET NON-VENTED HIGH-VOLUME INLET LHI BAXTER HEALTHCARE CORP H938173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 70 PERCENT DEXTROSE SOLUTION BY BAXTER HEALTHCARE| STERILE WATER FOR INJECTION BY BAXTER HEALTHCARE