BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABBOTT

    MDR report key: 8155418 · Received December 7, 2018

    Report

    Report Number
    8155418
    Event Type
    Injury
    Date Received
    December 7, 2018
    Date of Event
    October 10, 2018
    Report Date
    December 4, 2018
    Manufacturer
    ABBOTT
    Product Code
    OKR
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED WITH MULTIPLE VAD PUMP STOP, LOW FLOW ALARMS, AND WARNINGS TO REPLACE CONTROLLER - WHICH HAD BEEN HAPPENING SINCE (B)(6) 2018. HE WAS ADMITTED TO HOSP FOR PERC LEAD REPAIR. THIS WAS COMPLETED ON (B)(6) 2018. PT CONTINUED TO HAVE ALARMS OVER THE WEEKEND AND UNDERWENT HM2 PUMP EXCHANGE ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984299 ABBOTT HEARTMATE 2 LVAD OKR ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| L