BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY

    MDR report key: 8212661 · Received January 3, 2019

    Report

    Report Number
    3007042319-2019-00029
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 28, 2018
    Report Date
    April 18, 2019
    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

    CORRECTED SECTIONS: D4 - SERIAL NUMBER CORRECTED FROM (B)(4) TO (B)(4) ADDITIONAL PRODUCTS: 1650DE - (B)(4). D4 EXPIRATION DATE: 2017-11-30 UDI#: (B)(4). D10: YES, RETURN DATE: 2019-01-21 H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 2016-11-30 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 1650DE - (B)(4). D4 EXPIRATION DATE: 2018-05-31 UDI#: (B)(4). D10: YES, RETURN DATE: 2019-01-21 H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 2017-05-31 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 1650DE - (B)(4). D4 EXPIRATION DATE: 2017-11-30 UDI#: (B)(4). D10: YES, RETURN DATE: 2019-01-21 H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 2016-11-30 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 1650DE - (B)(4). D4 EXPIRATION DATE: 2017-11-30 UDI#: (B)(4). D10: YES, RETURN DATE: 2019-01-21 H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN H4: MFG DATE: 2016-11-30 H6 FDA RESULTS CODE(S): 3233 H6 FDA CONCLUSION CODE(S): 11 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

    PRODUCT EVENT SUMMARY: FIVE BATTERIES AND ONE CONTROLLER AC ADAPTER WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS OF (B)(4). REVEALED THAT THE BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF (B)(4), (B)(4), (B)(4), (B)(4), AND (B)(4) REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING; VISUAL INSPECTION REVEALED MARKS ON THE CONNECTORS DUE TO ATTEMPTS OF MATING WITH THE CONTROLLER CONNECTOR. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONNECTOR DAMAGE CAN BE ATTRIBUTED TO WEAR, LIKELY DUE TO NORMAL DISCONNECTION AND RECONNECTION BETWEEN THE POWER SOURCES' OUTPUT CABLES AND METAL POWER PORT CONNECTORS ON THE CONTROLLER. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE DAMAGED POWER SOURCE CONNECTORS AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. THE DAMAGES THAT WERE OBSERVED DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICES; THE POWER SOURCES WERE ABLE TO ADEQUATELY CONNECT TO A CONTROLLER. AS A RESULT, THE REPORTED EVENT WAS NOT CONFIRMED. ADDITIONAL PRODUCTS: CONTROLLER AC ADAPTER (B)(4). H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 19 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 19 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 19 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 216 H6 FDA CONCLUSION CODE(S): 67 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 19 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. OTHER DEVICES INVOLVED IN THIS EVENT:HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER/ (B)(4)/ MODEL #: 1430DE (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY/(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-11-30 , MFG DATE: 2016-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY ,(B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-05-31 , MFG DATE: 2017-05-31 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-11-30, MFG DATE: 2016-11-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY ,(B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-11-30 , MFG DATE: 2016-11-30 (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 PATIENT'S CONTROLLER AC ADAPTER AND BATTERIES HAD A POOR MECHANICAL CONNECTION. THE ADAPTER AND 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
    7275 HEARTWARE VENTRICULAR ASSIST SYSTEM - BATTERY VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1650DE

    Patients

    Seq Age Sex Outcome Treatment
    1 MCS UNKNOWN VAD