BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOR

    MDR report key: 2981563 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04855
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW HAS BEEN CONDUCTED WHICH REVEALED PRODUCT MET ALL OF THE ACCEPTANCE CRITERIA FOR RELEASE. THE PROBLEM WAS NOT CONFIRMED AND THE ASSIGNABLE CAUSE IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS VOMITING DURING USE OF AN INFUSOR. THE PRODUCT WAS FLOWING FAST DURING THE INFUSION. THERE WERE 0.25% BUPIVACAINE 120ML, 50MG/ML FENTANYL 24ML AND NORMAL SALINE 96ML BEING USED. BAXTER IS IN THE PROCESS OF OBTAINING ADDITIONAL INFORMATION REGARDING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    83847 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12B082

    Patients

    Seq Age Sex Outcome Treatment
    1 Other