BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 9813115 · Received March 10, 2020

    Report

    Report Number
    3007042319-2020-01707
    Event Type
    Malfunction
    Date Received
    March 10, 2020
    Date of Event
    March 9, 2020
    Report Date
    September 11, 2020
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: FOUR (4) BATTERIES WERE 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 RETURNED BATTERIES REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING. ADDITIONALLY, IT WAS OBSERVED THAT BATTERIES HAD EXCEEDED THE USEFUL OPERATING LIFE OF 500 CHARGE AND DISCHARGE CYCLES. THE HIGH BATTERY CYCLE COUNTS ARE AN ADDITIONAL OBSERVATION NOT RELATED TO THE REPORTED EVENT AND CAN BE ATTRIBUTED TO THE BATTERIES REACHING THE END OF THEIR USEFUL LIFE. VISUAL INSPECTION OF THREE BATTERIES REVEALED WORN MARKS ON THE BATTERIES OUTPUT CONNECTORS. AS A RESULT, THE REPORTED "WEAR MARKS" EVENT WAS CONFIRMED. VISUAL INSPECTION OF TOW BATTERIES ALSO REVEALED THAT THE RELEASE INDICATOR MARKERS ON BATTERIES' BATTERY OUTPUT CONNECTORS WERE ILLEGIBLE, LIKELY DUE TO WEAR AND/OR TO THE HANDLING OF THE DEVICE. THESE FINDINGS THAT WAS OBSERVED DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE; THE BATTERIES WERE ABLE TO ADEQUATELY CONNECT TO A TEST CONTROLLER. AS A RESULT, THE REPORTED POOR MECHANICAL CONNECTION EVENT COULD NOT BE CONFIRMED; HOWEVER, IT IS LIKELY THE WORN OUTPUT CONNECTORS AND/OR ILLEGIBLE RELEASE MARKERS CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO WEAR, LIKELY DUE TO NORMAL DISCONNECTION AND RE-CONNECTION BETWEEN THE BATTERY OUTPUT CABLE AND METAL POWER PORT CONNECTORS ON THE CONTROLLER. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6); D10: YES, RETURN DATE: 29-JUN-2020; H3: YES DEV RTN TO MFR? YES; H6: DEVICE CODE(S): C62968 H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 135, 180, 213 H6: FDA CONCLUSION CODE(S): 19, 133; D4: SERIAL OR LOT#: (B)(6); D10: YES, RETURN DATE: 29-JUN-2020; H3: YES DEV RTN TO MFR? YES; H6: DEVICE CODE(S): C62968 H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 180, 213 H6: FDA CONCLUSION CODE(S): 19, 133; D4: SERIAL OR LOT#: (B)(6); D10: YES, RETURN DATE: 29-JUN-2020; H3: YES DEV RTN TO MFR? YES; H6: DEVICE CODE(S): C62968 H6: FDA METHOD CODE(S): 10 H6: FDA RESULTS CODE(S): 180, 213 H6: FDA CONCLUSION CODE(S): 19, 133. 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION COMPLETION. PRODUCT EVENT SUMMARY: FOUR (4) BATTERIES WERE NOT RETURNED FOR EVALUATION. 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 POOR MECHANICAL CONNECTION EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED, TO CONNECTOR DAMAGE. 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. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 31-OCT-2016 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: 31-OCT-2016, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-JUN-2017 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: 30-JUN-2016, LABELED FOR SINGLE USE: NO, (B)(4); BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650DE / CATALOG #: 1650DE / EXPIRATION DATE: 30-APR-2017 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: 30-APR-2016, LABELED FOR SINGLE USE: NO, (B)(4). INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOUR BATTERIES EXHIBITED POOR MECHANICAL CONNECTIONS. IT ALSO REPORTED THAT TWO OF THE BATTERIES WERE "VERY USED ," SHOWED STRONG WEAR MARKS AND COULD BE WIGGLED ON THE CONTROLLER. IT WAS ALSO REPORTED THAT TWO OF THE BATTERIES HAD DIFFICULTIES TO BE ATTACHED TO A CONTROLLER BECAUSE THE CONNECTION WAS WORN. THE BATTERIES WERE EXPECTED TO BE REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274149 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 1104 VAD