BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 7830999 · Received August 29, 2018

    Report

    Report Number
    2916596-2018-03402
    Event Type
    Injury
    Date Received
    August 29, 2018
    Date of Event
    February 17, 2012
    Report Date
    September 12, 2018
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE PUMP WAS RETURNED AND EVALUATED UNDER MEDWATCH MFR REPORT #MDR-2018-30622-01. THE EVALUATION RESULTS ARE PROVIDED BELOW. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED DRIVELINE INFECTION COULD NOT BE CONCLUSIVELY DETERMINED. NO DEVICE-RELATED ISSUES WERE IDENTIFIED DURING THE EVALUATION OF THE PUMP. THE PUMP WAS RETURNED ASSEMBLED WITH THE DRIVELINE SEVERED APPROXIMATELY 1.5 INCHES FROM THE PUMP HOUSING; THE SEVERED PORTION OF THE DRIVELINE WAS NOT RETURNED. THE INFLOW CONDUIT AND OUTFLOW CONDUIT WERE RETURNED ATTACHED TO THEIR RESPECTIVE PUMP PORTS. (B)(4)APPEARED TO HAVE BEEN EXPOSED TO A FIXATIVE AGENT PRIOR TO RETURN FOR EVALUATION. EVALUATION OF THE SEALED INFLOW AND OUTFLOW CONDUITS REVEALED NO EVIDENCE OF DEVELOPED DEPOSITIONS OR THROMBUS FORMATIONS. UPON DISASSEMBLY OF THE PUMP, VISUAL INSPECTION OF THE BLOOD-CONTACTING SURFACES REVEALED NO EVIDENCE OF DEPOSITIONS OR THROMBUS FORMATIONS. THE PUMP WAS CLEANED AND THE BEARINGS, ROTOR AND BLOOD CONTACTING SURFACES WERE THEN EXAMINED UNDER A MICROSCOPE; NO ANOMALIES WERE OBSERVED THAT WOULD HAVE CONTRIBUTED TO A FUNCTIONAL ISSUE. ELECTRICAL CONTINUITY TESTING OF THE RETURNED PORTION OF THE DRIVELINE DID NOT REVEAL ANY DISCONTINUITIES OR SHORTS. THE PUMP WAS CLEANED, REASSEMBLED AND FUNCTIONALLY TESTED UNDER NORMAL OPERATING CONDITIONS USING A MOCK CIRCULATORY LOOP. THE DATA RETRIEVED FROM THAT TESTING REVEALED NORMAL PUMP POWER CONSUMPTION AND PRESSURE VALUES THAT MET MANUFACTURING SPECIFICATION AND THE DEVICE FUNCTIONED AS INTENDED. INFECTIONS ARE LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE LVAD ON (B)(6) 2011. IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS PRESENTED TO CLINIC S/P DLES TRAUMA WITH DRAINAGE, REDNESS, AND TENDERNESS. DLES CULTURE POSITIVE FOR MODERATE SERRATIA MARCESCENS, 2 COLONIES. BLOOD CULTURES NEGATIVE. STARTED ON ORAL CIPRO 750MG BY MOUTH TWICE A DAY FOR 30 DAYS. ON (B)(6) 2012 REPORTED THAT PATIENT'S DRAINAGE AND PAIN SIGNIFICANTLY DECREASED. ON (B)(6) 2012 PATIENT CALLED TO REPORT INCREASED PAIN AND DRAINAGE, SENT TO THE ER AND ADMITTED. CT ABDOMEN DEMONSTRATED NO DEFINITE FLUID COLLECTION AND NO FOCAL ABSCESS. THE PAIN FELT TO BE UNRELATED TO INFECTIOUS PROCESS AND ANTIBIOTICS STOPPED IN FAVOR OF INCREASED SITE CARE. BLOOD CULTURES NEGATIVE, DLES CULTURE STILL WITH MODERATE SERRATIA MARCESCENS AND NONPATHOGENIC NEISSERIA. ON (B)(6) 2012 THE PATIENT WAS SEEN IN THE CLINIC; CHANGING DRESSING BID DUE TO DRAINAGE, ANTIBIOTICS NOT RESTARTED IN FAVOR OF INCREASED SITE CARE. ON (B)(6) 2012 THE PATIENT WAS SEEN IN THE CLINIC FOR MUCH LESS DRAINAGE, DRESSING STYLE CHANGED TO DECREASE SKIN IRRITATION. THE PATIENT CONSENTED FOR TRANSPLANT EVAL/LISTING (INITIALLY IMPLANTED AS DT; TRANSPLANT EVALUATION PUT OFF DUE TO INSURANCE CHALLENGES). HOWEVER, ON (B)(6) 2012 THE PATIENT WAS LISTED AS 1A USING 30-DAY 1A VAD TIME. ON (B)(6) 2012 THE PATIENT WAS SEEN IN THE CLINIC FOR A RASH DUE TO DLES, INCREASED DRAINAGE, AND ABDOMINAL PAIN. DRESSING STYLE CHANGED AGAIN AS IT WAS FELT THAT THE PATIENT WAS NOT TOLERATING THE NEWER STYLE OF DRESSING CHANGE. THE PATIENT LATER ON WAS TRANSPLANTED ON (B)(6) 2012 AND THE PUMP WILL BE RETURNING FOR ROUTINE EVALUATION WHICH WAS CAPTURED UNDER MDR-2018-30622. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    671207 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 105306

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| O