BEUDAMED
    FDA Adverse Event Death Summary report: N

    AMBIT PCA PUMP

    MDR report key: 3030501 · Received March 26, 2013

    Report

    Report Number
    1722214-2013-00001
    Event Type
    Death
    Date Received
    March 26, 2013
    Date of Event
    February 15, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SUMMIT MEDICAL PRODUCT, INC
    Product Code
    MEA
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A MAN PASSED AWAY ON (B)(6) 2013 FOR UNK CAUSES, THE AMBIT PUMP WAS ATTACHED TO THE DECEASED AT THE TIME OF DEATH. THE DECEASED HAD SHOULDER SURGERY ON (B)(6) 2013. THE PUMP HAD BEEN ON THE DECEASED FOR APPROXIMATELY 23 HOURS. THE DECEASED WAS RECEIVING 0.25 BUPIVACAINE. AN UPDATE TO THIS MEDWATCH REPORT WILL BE FILED WHEN THE PUMP IS RELEASED FROM THE MEDICAL EXAMINER'S OFFICE AND TESTED OR IF AND WHEN A TOXICOLOGY REPORT IS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125146 AMBIT PCA PUMP AMBIT PCA PUMP MEA SUMMIT MEDICAL PRODUCT, INC 220262 A108017

    Patients

    Seq Age Sex Outcome Treatment
    1 Death