BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2822613 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04287
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 17, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THEREFORE THE REPORTED CONDITION COULD NOT BE CONFIRMED OR DUPLICATED AND AN ASSIGNABLE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW UP MEDWATCH WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510(K) NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FACILITY CONTACTED BAXTER (B)(4) TECHNICAL SERVICES TO REPORT A CLEARLINK CONTINU-FLO SOLUTION SET THAT THERE HAVE BEEN AN UNSPECIFIED NUMBER OF TIMES 'OVER THE PAST MONTH[, THAT] AFTER SPIKING [THE] IV BAG THE TUBING WON'T PRIME BEYOND THE DRIP CHAMBER.... THE CUSTOMER REPORTS THAT THEY NEED TO SQUEEZE [THE] IV BAG TO GET FLOW GOING.' THIS MALFUNCTION OCCURRED DURING PRIMING OF THE SET. THERE WAS NO PATIENT INVOLVEMENT, NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE R12A18022

    Patients

    Seq Age Sex Outcome Treatment
    1