BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 4863833 · Received June 23, 2015

    Report

    Report Number
    1416980-2015-26397
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 3, 2015
    Report Date
    June 4, 2015
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED AND THE EVALUATION IS IN PROGRESS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTING WAS PERFORMED BY SPIKING THE DEVICE INTO AN IN-HOUSE GLASS BOTTLE FILLED WITH DISTILLED WATER, PRIMING THE DEVICE, AND CHECKING FOR FLOW. THE DEVICE WAS FOUND TO PRIME AND FLOW NORMALLY WITH NO SPIKE FALL OUT NOTED. HOWEVER, THE CUSTOMER REPORTED THAT THE SET WAS USED WITH A NON-RIGID BAG. PER THE DEVICE¿S LABELING, THE SET IS ¿[F]OR USE WITH RIGID NONVENTED SOLUTION CONTAINERS.¿ THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A USE ERROR. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIKE OF A CLEARLINK VENTED PACLITAXEL SET FELL OUT OF A NON-BAXTER IV BAG FILLED WITH PACLITAXEL, LEADING TO A LEAK. THE TECHNICIAN STATED THAT THE INITIAL SPIKE CONNECTION FELT LOOSE. AFTER SPIKING THE BAG, THE SPIKE THEN SEPARATED FROM THE BAG. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406125 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R13J14154

    Patients

    Seq Age Sex Outcome Treatment
    1