BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2994309 · Received March 8, 2013

    Report

    Report Number
    1416980-2013-05584
    Event Type
    Malfunction
    Date Received
    March 8, 2013
    Date of Event
    February 10, 2013
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K123874
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT 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 INFORMATION BECOMES AVAILABLE. THIS IS THE SAME PRODUCT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THE REPORTED CONDITION COULD NOT BE CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING INFUSION OF AN UNKNOWN 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, CAUSING APPROXIMATELY 35CC OF CHEMOTHERAPY TO LEAK OUT AND RELEASE CHEMOTHERAPY VAPORS. THE PATIENT DID NOT EXPERIENCE AN ADVERSE EVENT OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS LEAK. THIS IS REPORT 4 OF 4.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100195 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CHEMOTHERAPY