BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3073268 · Received April 23, 2013

    Report

    Report Number
    1416980-2013-10108
    Event Type
    Malfunction
    Date Received
    April 23, 2013
    Report Date
    March 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K981792
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK PACLITAXEL SET LEAKED. AFTER THE USER INITIATED THE CHEMOTHERAPY INFUSION, THE SET WAS OBSERVED TO BE LEAKING AT THE ATTACHMENT RIGHT AT THE FILTER. THE LEAKING OCCURRED AT THE BEDSIDE BUT THE PATIENT AND STAFF WERE NOT EXPOSED TO THE CHEMOTHERAPY SOLUTION. THE CUSTOMER REPORTED THE SET WAS LEAKING WHILE IT WAS ATTACHED TO THE PUMP AND HE WAS ABLE TO WORK WITH THE DOCTOR IN ORDER TO HAVE THE PATIENT RECEIVE THE FULL DOSE OF CHEMOTHERAPY TREATMENT. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174568 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN CHEMOTHERAPY, UNKNOWN INFUSION PUMP