BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II

    MDR report key: 13585725 · Received February 18, 2022

    Report

    Report Number
    13585725
    Event Type
    Injury
    Date Received
    February 18, 2022
    Date of Event
    May 26, 2021
    Report Date
    August 26, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT ADMITTED TO OUTSIDE HOSPITAL (OSH) WITH PAST WEEK OF DARK URINE AND LOH OF 1463 (PRIOR TO ADMISSION LOH LIMITS 200'S). PT TAKING ASPIRIN AND COUMADIN AS ORDERED. INR WITHIN THERAPEUTIC RANGES. ON ADMISSION TO (B)(6), LOH 1050 WITH AST, ALT, AND TOTAL BILIRUBIN WNL AND LVAD FLOWS 7'S AND POWERS 5-6'S (NORMAL RANGES FOR POWER AND FLOWS 5). HEPARIN STARTED. PENTOXIFYLLINE STARTED. LOH DECREASED TO 656 BY DISCHARGE.

    Description of Event or Problem · 0

    ON (B)(6) 2021 PATIENT ADMITTED TO OUTSIDE HOSPITAL (OSH) WITH HEMOLYSIS AND LDH OF 1463 (PRIOR TO ADMISSION LOH LIMITS 200'S). PT TAKING ASPIRIN AND "COURNADIN" AS ORDERED. INR WITHIN THERAPEUTIC RANGES. HEPARIN STARTED AND LDH DECREASED. PT REFUSED VAD CHANGE OUT AT THIS TIME. ON "(B)(6)" PATIENT ADMITTED TO DUKE WITH LDH 1558 WITH AST, ALT, AND TOTAL BILIRUBIN WNL AND LVAD FLOWS 6'S AND POWERS S'S (NORMAL RANGES FOR POWER AND FLOWS 5). HEPARIN STARTED. PT TAKEN TO OPERATING ROOM ON (B)(6) 2021 FOR PUMP EXCHANGE. THROMBUS NOTED TO OLD PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108589 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention| H