BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 8367426 · Received February 25, 2019

    Report

    Report Number
    3007042319-2019-04688
    Event Type
    Malfunction
    Date Received
    February 25, 2019
    Date of Event
    January 29, 2019
    Report Date
    March 6, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000475
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE CONTROLLER WAS NOT RETURNED FOR EVALUATION; SIX BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED BATTERIES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE DUPLICATED DURING BENCH TESTING; THE BATTERIES DID NOT EXPERIENCE A POWER SWITCHING EVENT, BEEPING, AND WERE ABLE TO ADEQUATELY PROVIDE POWER TO A TEST CONTROLLER. LOG FILE ANALYSIS WAS NOT CONDUCTED SINCE LOG FILES WERE NOT AVAILABLE. AS A RESULT, THE REPORTED EVENTS COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED TO A COMMUNICATION ERROR AND/OR TO MOMENTARY DISCONNECTION DUE TO FRETTING CORROSION OF THE CONTROLLER POWER PORT PINS. ADDITIONAL PRODUCTS: BATTERY / (B)(6) D10: YES, RETURN DATE: 2019-02-14 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6) D10: YES, RETURN DATE: 2019-02-14 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6) D10: YES, RETURN DATE: 2019-02-14 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6) D10: YES, RETURN DATE: 2019-02-14 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6) D10: YES, RETURN DATE: 2019-02-14 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 BATTERY / (B)(6) D10: YES, RETURN DATE: 2019-02-14 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 67 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. CONCOMITANT MEDICAL PRODUCTS: DDBC3D4 ICD AND 5076-45 LEAD, IMPLANTED: (B)(6) 2015. 6935M55 LEAD, IMPLANTED: (B)(6) 2018. OTHER DEVICES INVOLVED IN THIS EVENT: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, SERIAL #: (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-04-30, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2019-02-14. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-04-30. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, SERIAL #: (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-05-30, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2019-02-14. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-05-30. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, SERIAL #: (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-05-30, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2019-02-14. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-05-30. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, SERIAL #: (B)(4) / MODEL #: 1650 / EXPIRATION DATE: 2018-03-31, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2019-02-14. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-03-31. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, SERIAL #: (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-05-30, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2019-02-14. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-05-30. LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY, SERIAL #: (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-04-30, UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: YES, RETURN DATE: 2019-02-14. DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-04-30. LABELED FOR SINGLE USE: NO. (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 THE CONTROLLER WAS NOT RECOGNIZING THE BATTERY CONNECTED TO POWER PORT ONE, AND THERE WAS POWER SWITCHING WITH ALL OF THE BATTERIES. THE CONTROLLER REMAINS IN USE AND THE BATTERIES WERE EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159550 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000475

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR 1103 VAD