BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 3962037 · Received July 28, 2014

    Report

    Report Number
    1416980-2014-24488
    Event Type
    Malfunction
    Date Received
    July 28, 2014
    Report Date
    July 3, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED BY THE CUSTOMER AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WERE 1 TO 2 ML OF AIR IN THE LINE OF A CLEARLINK CONTINU-FLO SOLUTION SET. THIS OCCURRED WHILE INFUSING ACETAMINOPHEN IN A 100ML GLASS BOTTLE THROUGH A SECONDARY SET INTO THE PRIMARY CLEARLINK DUO VENT SET. THE REPORTER STATED THAT THE DEVICE WAS ALSO BEING USED WITH A SIGMA PUMP, AND THE INFUSION RATE WAS 400ML/HR. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    437448 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 CLEARLINK SECONDARY MEDICATION SET (2C7462)| SIGMA PUMP| 100 ML OFIRMEV