BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 1976518 · Received January 28, 2011

    Report

    Report Number
    9610847-2011-00002
    Event Type
    Other
    Date Received
    January 28, 2011
    Date of Event
    January 2, 2011
    Report Date
    January 7, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    WE RECEIVED 10 UNUSED UNITS FROM VARIOUS LOT NUMBERS FOR EVAL. VISUAL AND MICROSCOPIC EXAMINATIONS DID NOT REVEAL ANY PHYSICAL OR MECHANICAL DAMAGE TO ANY OF THE UNITS' COMPONENTS. COLUMN TEAR ASSESSMENT WAS ALSO PERFORMED AND NO TEARS WERE OBSERVED. ACTUATED AND UN-ACTUATED LEAK TESTING WAS THEN PERFORMED AND NO LEAKAGE WAS OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO IRREGULARITIES DURING THE MANUFACTURE OF REPORTED LOT NUMBER 7192346. CONCLUSIONS: THE ACTUAL UNIT INVOLVED WAS NOT RETURNED FOR EVAL, AND THEREFORE, A ROOT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. THE REP UNITS RETURNED MET MFG SPECIFICATIONS. (B)(4).

    Description of Event or Problem · 1

    PATIENT'S BLOOD PRESSURE BEGAN TO DROP. EPINEPHRINE DRIP STARTED 0.02 MCG/KG/MIN, DOSE INCREASED OVER SEVERAL HOURS TO 0.08. BLOOD PRESSURE CONTINUED TO BE LOW, SO THE BABY WAS GIVEN PUSHES OF VOLUME EXPANDER. BLOOD SUGAR TESTED 0. PUSH OF GLUCOSE AND SAMPLE SENT TO LAB QUICKLY (RESULT 23). THEY GAVE ANOTHER BOLUS OF GLUCOSE. THEN FULL SEPTIC WORKUP. EVENTUALLY AT ABOUT 3:00PM, RN FOUND A 5-INCH AREA UNDER THE BUNTING THAT WAS WET. AT THIS POINT, THEY DISCOVERED LEAKING THE BD Q-SYTE DEVICE. NURSE BELIEVES IT WAS COMING FROM THE JUNCTION OF WHERE THE BD Q-SYTE THREADS CONNECT TO THE PICC LINE, HOWEVER, THE BD Q-SYTE WAS NOT SAVED. AFTER THE BD Q-SYTE WAS REPLACED, PATIENT RECEIVED A BOLUS OF HIGHER CONCENTRATED MEDICATIONS THAT WERE IN LINE THAT HAD NOT BEEN DELIVERED YET. AFTER THE MEDS HERE DELIVERED, THE PATIENT'S BLOOD SUGAR WENT UP TO 257 AND MEAN BLOOD PRESSURE WENT UP TO 72 (NORMAL FOR THIS BABY IS 26). MEDS/FLUIDS WERE BROUGHT DOWN (ADJUSTED AND TESTED) AS QUICKLY AS POSSIBLE UNTIL THEY WERE IN A NORMAL RANGE (BY 5:10PM).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD Q-SYTE LUER ACCESS SPLIT SEPTUM INTRAVASCULAR ADMINISTRATION SET FPA BECTON DICKINSON INFUSION THERAPY SYSTEMS NA 7192346

    Patients

    Seq Age Sex Outcome Treatment
    1 10 DA Other