BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD Q-SYTE LUER ACCESS SPLIT SEPTUM

    MDR report key: 2540324 · Received April 12, 2012

    Report

    Report Number
    9610847-2012-00035
    Event Type
    Injury
    Date Received
    April 12, 2012
    Date of Event
    March 27, 2012
    Report Date
    April 11, 2012
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FPA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVALUATION. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    TRIPLE CVC WAS PLACED RIGHT JUGULAR VESSEL. PT'S BLOOD PRESSURE WAS UNSTABLE SINCE EARLY MORNING OF (B)(6) AND LOWERING OF BP (60-70MMHG) HAD BEEN OBSERVED WHEN THE HEALTH CARE WORKER CHANGED THE BODY POSITION AND NORADRENALIN SYRINGE. TO PREVENT THE PRESSURE DECREASE, PRIMARY DOCTOR ORDERED TO ADMINISTER NORADRENALINE FROM THE BLUE LINE WHEN CHARGING THE NORADRENALINE SYRINGE AT WHITE LINE. AT 13:00PM ON (B)(6), THE HEALTH CARE WORKER TOOK OUT THE EXTENSION TUBING + SALINE FROM THE BD Q-SYTE AT THE BLUE LINE AND CONNECTED THE NORADRENALINE LINE TO THE BLUE LINE. ACCORDINGLY, THE ORIGINAL SALINE LINE AT THE BLUE LINE WAS THEN CONNECTED IT TO BROWN LINE. AFTER FOUR MINUTES, THE PT'S BLOOD PRESSURE WENT DOWN 57/3MMHG, HEART RATE WAS ABOUT 70S AND SPO2 WAS UNMEASURABLE. WHEN THE HEALTH CARE WORKER CHECKED THE LINE, LEAKAGE OF NORADRENALIN FROM BD Q-STYLE HOUSING AT THE BLUE LINE WAS OBSERVED. PER THE PRIMARY DOCTOR'S INSTRUCTION, THE BD Q-SYTE WAS CHANGED TO A NEW ONE AND IMMEDIATELY FOLLOWING ACTION WAS TAKEN THE NORADRENALIN DOSING RATE WAS CHANGED TO 15ML/HR AND FIO2 UP TO 1.00 ON THE BEDSIDE. WITH THIS TREATMENT, THE PT'S BLOOD PRESSURE WENT BACK TO 80S, HEART RATE: 120 AND SPO2: 90S.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Other HEPARIN LOCK| NORADRENALINE| NORMAL SALINE