BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3851438 · Received June 5, 2014

    Report

    Report Number
    1416980-2014-18000
    Event Type
    Malfunction
    Date Received
    June 5, 2014
    Date of Event
    May 12, 2014
    Report Date
    May 13, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ACTUAL SAMPLE WAS NOT RETURNED, HOWEVER, A PHOTOGRAPH WAS PROVIDED FOR EVALUATION. PHOTOGRAPHIC INSPECTION DID NOT NOTE ANY FLOW ISSUES. THE REPORTED PROBLEM COULD NOT BE VERIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE LOT 13K047, WAS MANUFACTURED BETWEEN OCTOBER 14, 2013 ¿ OCTOBER 15, 2013. IF ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR EXPERIENCED A NO FLOW. THIS MALFUNCTION WAS OBSERVED 24 HOURS AFTER THE START OF A TAZOCIN INFUSION. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WAS NO 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
    329210 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 13K047

    Patients

    Seq Age Sex Outcome Treatment
    1 TAZOCIN 1800MG