BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACCESS

    MDR report key: 2994266 · Received March 8, 2013

    Report

    Report Number
    1416980-2013-05580
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORT OF A LEAK DUE TO THE CRACKED BURETTE WAS DETERMINED TO BE CAUSED BY THE NURSE ATTEMPTING TO FORCE THE DRAINAGE OF RESIDUAL VOLUME OF CHEMOTHERAPY AND INTENTIONALLY CLOSING THE AIRWAY LEVER OF THE VENT FOR THE BURETROL SET. DOING THIS, WHILE CONTINUING TO ALLOW THEIR INFUSION PUMP TO INFUSE, WOULD GENERATE A VACUUM IN THE BURETTE CHAMBER. THEREFORE, THE VACUUM THAT WAS INTENTIONALLY GENERATED IN ORDER TO USE UP THE ENTIRE DRUG IN THE BAG LED TO A VACUUM THAT STRESSED THE BURETTE CHAMBER. THEN, WHEN THE AIRWAY LEVER WAS OPENED, THE BUILT UP PRESSURE CAUSED THE BURETTE TO CRACK. COMPARING THE USE SCENARIO DESCRIBED ABOVE TO THE LABEL COPY FOR THE 2H7565 PRODUCT, (B)(4), IT SHOULD BE NOTED THAT THERE IS NO ALLOWANCE PROVIDED FOR IN THE DIRECTIONS OF THE LABEL TO USE THE SET IN THIS MANNER. THE CAUTIONS INSTRUCT TO ENSURE THE AIRWAY LEVER IS OPEN WHEN USED AS A BURETTE SET.

    Additional Manufacturer Narrative · 1

    (B)(4). COMPARING THE USE SCENARIO TO THE LABEL COPY FOR THE 2H8865 PRODUCT, (B)(4), "PRINTING PLATE 2H8865 CLEARLINK SYSTEM BURETROL ADD-ON SET 150 ML VALVELESS BURETTE SLIDE CLAMP LUER ACTIVATED VALVE" (ISSUE DATE: (B)(4) 2013), IT SHOULD BE NOTED THAT NO ALLOWANCE IS PROVIDED FOR IN THE DIRECTIONS OF THE LABEL TO USE THE SET IN THIS MANNER. THE CAUTIONS INSTRUCT TO ENSURE THE AIRWAY SLIDE CLAMP IS OPEN WHEN USED AS A BURETTE SET. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR ANALYSIS AND THE LOT NUMBER WAS UNKNOWN; THEREFORE A SAMPLE EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED DURING INFUSION OF A CHEMOTHERAPY AGENT, A NURSE CLAMPED OFF A NON-DEHP BURETROL SET ABOVE AND BELOW THE BURETTE. WHEN THE MISTAKE WAS CORRECTED AND THE AIRWAY LEVER WAS OPEN, THE SUDDEN RELEASE OF BUILT-UP PRESSURE CAUSED THE BURETTE TO CRACK, RESULTING IN APPROXIMATELY 35CC OF AN UNKNOWN CHEMOTHERAPY DRUG TO LEAK OUT AND RELEASE CHEMOTHERAPY VAPORS. THE MOTHER OF THE PATIENT WAS EXPOSED TO THE CHEMOTHERAPY VAPORS WHICH CAUSED NAUSEA AND VOMITING. THE MOTHER WAS TAKEN TO THE EMERGENCY ROOM (ER) AND TREATED WITH INTRAVENOUS (IV) FLUIDS AND ZOFRAN (DOSAGE, ROUTE AND FREQUENCY WERE NOT REPORTED). OUTCOME WAS NOT REPORTED. THIS IS REPORT 2 OF 4 FOR THE IDENTIFIED PRODUCT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98555 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention UNKNOWN CHEMOTHERAPY DRUG