BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3841682 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17513
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NO OBVIOUS DEFECTS. A FUNCTIONAL TEST WAS PERFORMED IN WHICH SOLUTION WAS PUMPED THROUGH THE SET AT 50 ML PER HOUR; NO LEAKAGE WAS IDENTIFIED. INSPECTION OF PHOTOGRAPHS OF THE DEVICE SPIKED INTO A DEXMEDETOMIDINE VIAL WAS PERFORMED BUT WAS UNABLE TO IDENTIFY ANY ISSUES WITH THE SET. THE REPORTED CONDITION WAS UNABLE TO BE VERIFIED VIA EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIKE OF A CLEARLINK VENTED CONTINU-FLO SOLUTION SET HAD A LOOSE CONNECTION TO A VIAL OF DEXMEDETOMIDINE, CAUSING A LEAK. THE REPORTER STATED ¿WHEN THEY SPIKE THE VIAL, THE VIAL ACTUALLY LEAKS OUT, IT HAS LOOSE CONNECTION.¿ THIS OCCURRED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319471 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1