BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3020301 · Received March 25, 2013

    Report

    Report Number
    1416980-2013-07194
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Report Date
    February 28, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RECEIVED FOR EVALUATION. THEREFORE THE CUSTOMER REPORTED CONDITION COULD NOT BE CONFIRMED, NOR COULD A CAUSE BE DETERMINED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THE SUSPECTED LOTS: R12K28120 AND R12L19085. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOTS. THIS IS THE SAME EVENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A CLEARLINK CONTINU-FLO DUO VENT SOLUTION SET HAD EXPERIENCED A NO FLOW. THE DAY SURGERY NURSE PRIMED THE SET AND THEN HUNG IT FOR A GRAVITY INFUSION ON A PATIENT. IT WAS UNKNOWN IF A PATIENT WAS CONNECTED WHEN THE NURSE OBSERVED THE NO-FLOW. HOWEVER THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, NOR ADVERSE EVENT IN ASSOCIATION WITH THIS EVENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE. THIS IS REPORT 3 OF 6 FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    122782 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 NORMAL SALINE