BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4122412 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01651
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    June 9, 2014
    Report Date
    August 20, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP REMAINS IN USE SUPPORTING THE PT. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    BASED ON THE INFORMATION AVAILABLE TO THE MANUFACTURER, A SPECIFIC CAUSE FOR THE REPORTED GI BLEED COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE PATIENT REMAINS ONGOING ON LVAD SUPPORT AND NO FURTHER RELATED ISSUES HAVE BEEN REPORTED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PT WAS ADMITTED INTO THE HOSPITAL ON (B)(6) 2014 FOR A GI BLEED. THE PT'S HEMOGLOBIN WAS 9.0 AND HEMATOCRIT WAS 27 AT THAT TIME. THE PT UNDERWENT AN UPPER GI ENDOSCOPY AND COLONOSCOPY. THERE WAS NO ACTIVE SOURCE OF BLEEDING FOUND. THE PT RECEIVED A TRANSFUSION OF 2 UNITS OF PACKED RED BLOOD CELLS AND WAS DISCHARGED ON (B)(6) 2014. HIS INR WAS 1.4 ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579284 HEARTMATE II LVAS DSQ; LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 127376

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention