BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3142680 · Received June 3, 2013

    Report

    Report Number
    1416980-2013-14086
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K840760
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, PICTURES OF THE SAMPLE ARE PROVIDED. SHOULD ANY ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION. A PHOTOGRAPH OF THE DEVICE WAS PROVIDED BY THE CUSTOMER. A LEAK COULD NOT BE CONFIRMED FROM THE PHOTOGRAPHIC INSPECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN AIR ELIMINATING TUBING SET WAS LEAKING FROM A HOLE. THE REPORTER STATED THAT THEY "WENT TO CHECK WHY PCA WAS BEEPING I OPENED UP PUMP AND LATCH WHERE THE TUBING SITS IN AND FLUID WAS LEAKING ALL OVER. WHEN LOOKING AT TUBING THERE IS A HOLE IN THE CARTRIDGE THAT GOES INTO THE PUMP." THIS OCCURRED DURING PATIENT INFUSION WITH A BAXTER PUMP. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244349 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1 IPUMP