BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 13677834 · Received March 7, 2022

    Report

    Report Number
    3007042319-2022-02852
    Event Type
    Malfunction
    Date Received
    March 7, 2022
    Date of Event
    March 1, 2022
    Report Date
    October 17, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-0946-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER 2.0 MODEL #: 1420/ CATALOG #: 1420 / EXPIRATION DATE: (B)(6)2019 / SERIAL # : (B)(4) UDI #: (B)(4) DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MFR: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN . MFG DATE: 03-DEC-2018. LABELED FOR SINGLE USE: NO. PATIENT IME CODE(S):E2403. IMF CODE(S): F26. IMG CODE(S): G04035 FDA DEVICE CODE(S): A051203. FDA RESULTS CODE(S): C21. FDA CONCLUSION CODE(S): D16. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    ### A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE VENTRICULAR ASSIST DEVICE (VAD) AND CONTROLLER WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED TWO (2) VAD DISCONNECT ALARMS LOGGED ON 1/MAR/2022 AT 16:57:26 AND 17:53:12. BETWEEN THE VAD DISCONNECT ALARMS, A VAD STOPPED ALARM WAS LOGGED AT 16:59:10 DUE TO A FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. TWO (2) ADDITIONAL VAD DISCONNECT ALARMS WERE LOGGED ON (B)(6) 2022 AT 10:41:42 AND 10:45:17. AS A RESULT, THE REPORTED VAD STOP, VAD DISCONNECT ALARMS AND ¿VAD TAKING LONGER TO RESTART¿ EVENTS WERE CONFIRMED. THE REPORTED LOOSE DRIVELINE CONNECTOR EVENT COULD NOT BE CONFIRMED. APPLICABLE RISK DOCUMENTATION AND EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED LOOSE DRIVELINE CONNECTION CAN BE ATTRIBUTED, BUT NOT LIMITED, TO A FAULTY LOCKING MECHANISM, DUE TO A DISPLACED RETENTION NUT AND/OR FOREIGN MATERIAL AT THE SITE OF THE LOCKING MECHANISM. BASED ON RISK DOCUMENTATION AND THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE VAD DISCONNECT ALARMS CAN BE ATTRIBUTED, BUT NOT LIMITED, TO A MARGINAL DRIVELINE CONNECTION, AS REPORTED IN THE EVENT DETAILS, CONTAMINATION BY FOREIGN MATERIAL OF THE DRIVELINE CONNECTOR, AND/OR THE DROP EVENT DESCRIBED IN THE EVENT DETAILS. THE MOST LIKELY ROOT CAUSE OF THE VAD STOPPED ALARM CAN BE ATTRIBUTED TO A FAILURE OF THE PUMP TO RESTART AFTER SEVERAL ATTEMPTS. THE VAD WAS NOT IN SCOPE OF FCA CVG-21-Q3-21. CAPA (B)(4)IS INVESTIGATING PUMP FAILURES TO RESTART OUTSIDE THE SUBPOPULATION OF FCA CVG-21-Q3-21. ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6) H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C23, C19 H6: FDA CONCLUSION CODE(S): D11, D10 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 · 0

    A SUPPLEMENTAL CORRECTION IS BEING SUBMITTED FOR INCLUSION OF THIS EVENT AS BEING IN-SCOPE FOR RECALL WITH Z-0946-2021. THIS EVENT WAS SUBMITTED HISTORICALLY AND HAS BEEN DEEMED IN-SCOPE FOR THE FIELD CORRECTIVE ACTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED MULTIPLE VAD STOPS DUE TO A LOOSE DRIVELINE CONNECTOR. REVIEW OF LOG FILES REVEALED MULTIPLE VAD STOPPED AND VAD DISCONNECT ALARMS. IT WAS ALSO FOUND THAT THE VAD TOOK LONGER THAN NORMAL TO RESTART. IT WAS ALSO REPORTED THAT THE PATIENT ACCIDENTLY DROPPED THE CONTROLLER. NO VISIBLE CONTAMINATION INSIDE THE CONNECTOR OR CONTROLLER WERE OBSERVED. THE DRIVELINE WAS NOTED TO BE EASY TO DISCONNECT FROM THE CONTROLLER. THE CONNECTOR WAS CLEANED AND SECURED WITH TAPE. THE VAD AND CONTROLLER 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
    1215867 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male