BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 7488253 · Received May 4, 2018

    Report

    Report Number
    3007042319-2018-01746
    Event Type
    Malfunction
    Date Received
    May 4, 2018
    Date of Event
    April 5, 2018
    Report Date
    October 24, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002639
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: SIX BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. THE HVAD PUMP (B)(4) WAS NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE BATTERIES REVEALED THAT THE UNITS PASSED VISUAL INSPECTION AND FUNCTIONAL EXAMINATION. THE REPORTED HIGH POWER EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED SEVERAL INCREASES IN POWER CONSUMPTION WITHIN THE ANALYZED PERIOD AND 16 HIGH WATT ALARMS LOGGED SINCE 01MAR2018. LOG FILE ANALYSIS DID NOT REVEAL ANY INDICATION THAT THE BATTERY USE CONTRIBUTED TO THE POWER INCREASES. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE HIGH POWER EVENT. BASED ON THE RISK DOCUMENTATION, POSSIBLE CAUSES OF THE REPORTED HIGH POWER EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION, HIGH FLOWS, AND/OR PATIENT RELATED FACTORS. ADDITIONAL PRODUCTS: BATTERY (B)($). MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4), RETURN DATE: 2018-04-18, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4), RETURN DATE: 2018-04-18, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #:(B)(4), RETURN DATE: 2018-04-18, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #:(B)(4), RETURN DATE: 2018-04-18, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4) HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4), RETURN DATE: 2018-04-18, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-08-31 UDI #: (B)(4), RETURN DATE: 2018-04-18, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2017-08-31 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH WATT ALARMS WERE TRIGGERED WHEN THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED AN INCREASED POWER TREND. THE PATIENT WAS BROUGHT TO THE CLINIC FOR EQUIPMENT INSPECTION. IT WAS NOTED THAT THE PATIENT WAS TWISTING THE POWER CABLES OF THE BATTERIES WHEN ATTACHING THEM TO THE CONTROLLER. IT WAS FELT THAT THE TWISTING OF THE BATTERY POWER CABLES CONTRIBUTED TO THE INCREASED POWER TREND AND THE PATIENT DID NOT EXHIBIT ANY SYMPTOMS TO INDICATE THE POWER INCREASE WAS DUE TO THROMBOSIS. THE BATTERIES WERE EXCHANGED AND THE PUMP REMAINS IN USE. THE INCREASED POWER RESOLVED WITH THE REPLACEMENT BATTERIES. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329722 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103 00888707002639

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DVBB1D4 ICD, 6947M62 LEAD