BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3911684 · Received May 28, 2014

    Report

    Report Number
    2916596-2014-00844
    Event Type
    Injury
    Date Received
    May 28, 2014
    Date of Event
    April 3, 2014
    Report Date
    April 28, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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 MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE REPORTED EVENT AND THE DEVICE COULD NOT BE DETERMINED. IT WAS COMMUNICATED THAT THE PATIENT REMAINED ONGOING ON PUMP SUPPORT UNTIL EXPIRING ON JULY 6, 2014. THE PUMP WAS RETURNED AND EVALUATED UNDER MFR'S MEDWATCH # 2916596-2014-01364. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. 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 ADMINISTRATOR THAT THE PT WAS ADMITTED FOR SHORTNESS OF BREATH AND WEAKNESS WITH THE PUMP SPEED SET AT 8800 RPM. THE PT WAS STARTED ON MILRINONE WAS BEING WORKED UP FOR A HEART TRANSPLANT. THE RAMP STUDY WAS STOPPED WHEN THE PULMONARY CAPILLARY WEDGE PRESSURE (PCWP) REACHED 5 MMHG, TO AVOID THE POSSIBILITY OF A SUCTION EVENT. AT THE CONCLUSION OF THE CASE THE PUMP SPEED WAS SET AT 9600 RPM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314827 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106015 130931

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention