BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 8159925 · Received December 13, 2018

    Report

    Report Number
    3007042319-2018-07107
    Event Type
    Malfunction
    Date Received
    December 13, 2018
    Date of Event
    December 5, 2018
    Report Date
    March 20, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: THE CONTROLLER, FOUR BATTERIES, TWO AC ADAPTERS, AND ONE DC ADAPTER WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS WAS NOT CONDUCTED SINCE LOG FILES COVERING THE EVENT DATE WERE NOT AVAILABLE. AS A RESULT, THE REPORTED EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENTS CAN BE ATTRIBUTED TO COMMUNICATION ERRORS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND THE DEVICES. HOWEVER, THE REPORTED DISCONNECT ALARMS ARE MOST LIKELY ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND DEVICES. 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 · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTION TO DEVICE EVALUATION. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 D4: SERIAL #: (B)(6). H6: FDA METHOD CODE(S): 4112, 4114 H6: FDA RESULTS CODE(S): 3221 H6: FDA CONCLUSION CODE(S): 67 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. 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 AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE 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 REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM 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. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2019-02-28, MFG DATE: 2018-02-28 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2019-02-28 MFG DATE: 2018-02-28 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2019-02-28 MFG DATE: 2018-02-28 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2019-02-28 MFG DATE: 2018-02-28 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER/ (B)(4) / MODEL #: 1430DE, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER/(B)(4)/ MODEL #: 1430DE (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER / (B)(4)/ MODEL #: 1440 (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 THERE WAS POWER SWITCHING ON THE BATTERIES, CONTROLLER, CONTROLLER AC ADAPTER, AND CONTROLLER DC ADAPTER. THERE WERE ALSO POWER DISCONNECT ALARMS HEARD SEVERAL TIMES. SERVICING WAS PERFORMED AND THE BATTERIES, CONTROLLER, CONTROLLER AC ADAPTER, AND CONTROLLER DC ADPATER REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002670 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1420

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR 1104 VAD