BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 8417407 · Received March 6, 2019

    Report

    Report Number
    8417407
    Event Type
    Death
    Date Received
    March 6, 2019
    Date of Event
    February 24, 2019
    Report Date
    March 1, 2019
    Manufacturer
    ABBOTT
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT HAS SIGNIFICANT HISTORY OF REMOVE HM II IMPLANT (B)(6) 2019 WITH CLINICAL COURSE COMPLICATED BY DRIVELINE SHORT TO SHIELD. AFTER AN UNSUCCESSFUL ATTEMPT TO REPAIR HIS EXTERNAL DRIVELINE, THE PT UNDERWENT PUMP EXCHANGE(B)(6) 2018. PATIENT WAS SUBSEQUENTLY ADMITTED IN BOTH (B)(6) AND (B)(6) 2018 WITH ELEVATED LDH AND CLINICAL FINDINGS CONSISTENT WITH PUMP THROMBUS. UNFORTUNATELY, BOTH EVENTS OCCURRED IN THE SETTING OF PATIENT DEFERRING RECOMMENDATIONS FOR LOVENOX BRIDGING IN THE SETTING OF SUBTHERAPEUTIC INR LEVELS. PATIENT DID UNDERGO TREATMENT WITH TPA, WHICH PRODUCED A TEMPORARY IMPROVEMENT IN LDH LEVELS. HE HAS BEEN MAINTAINED ON ASPIRIN, BRILINTA AND ELIQUIS FOR ANTICOAGULATION AFTER PREVIOUSLY DEFERRING FURTHER TREATMENT WITH COUMADIN. PATIENT WAS NOT A CANDIDATE FOR PUMP EXCHANGE SECONDARY TO LONGSTANDING HISTORY OF NONCOMPLIANCE. PATIENT WAS ADMITTED (B)(6) 2019 FOR ABDOMINAL PAIN AND DYSPNEA. AT THAT TIME, HE ELECTED TO GO HOME WITH HOSPICE. PATIENT WAS ADMITTED (B)(6) 2019 DUE TO WORSENING DYSPNEA. PT STATED HE HAD BEEN TAKING HIS ASA, TICAGRELOR AND APIXABAN AS PRESCRIBED. ADDITIONALLY, HE COMPLAINED OF SEVERE PAIN IN ABDOMEN, RADIATING TO HIS BACK. PATIENT REPORTED A POOR APPETITE AND FREQUENT VOMITING. HE NOTED SOME RECENT VAD ALARMS AT HOME; HOWEVER, HE COULD NOT RECALL WHAT THEY WERE. THE PATIENT DENIED ANY DARK URINE, HEADACHE, FEVER, CHILLS, MUCOUS PRODUCTION OR CHEST PAIN AT THE TIME OF ADMISSION. PATIENT ADMITTED TO THE HOSPITAL AS A DNR IV AND HOSPICE WAS RECONSULTED. DURING HOSPITALIZATION, PATIENT WAS FOUND TO BE SEVERELY ANEMIC AT 5.7, HAD AN ELEVATED LDH OF 3251 AND WORSENING RENAL FAILURE; PRESUMABLY FROM PUMP THROMBOSIS. THE PATIENT RECEIVED A TOTAL OF 2 UNITS OF PRBCS OVER HOSPITAL COURSE AND WAS GIVEN IV BUMETANIDE AND DIURIL FOR VOLUME OVERLOAD. PATIENT AGREED TO RETURN HOME WITH HOSPICE. GIVEN RENAL FUNCTION AND SIGNIFICANT ANEMIA, TICAGRELOR AND APIXABAN WERE DISCONTINUED. LORAZEPAM AND HYDROMORPHONE FOR COMFORT. OUR TEAM WAS NOTIFIED ON 02/25 BY PATIENT'S HOSPICE COMPANY THAT THE PATIENT PASSED AWAY AT HOME ON (B)(6) 2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190978 ABBOTT HEARTMATE II LVAS DSQ ABBOTT

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Death