BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7275229 · Received February 15, 2018

    Report

    Report Number
    3007042319-2018-00644
    Event Type
    Malfunction
    Date Received
    February 15, 2018
    Date of Event
    January 19, 2018
    Report Date
    October 29, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1903-2018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    CORRECTIONS: H10 PRODUCT EVENT SUMMARY: THE CONTROLLER (B)(4) AND FOUR BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS OF THE RETURNED CONTROLLER (B)(4) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. THE LOG FILES OF THE CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(4), REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. 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: THE LOG FILES OF THE CONTROLLER IN USE DURING THE REPORTED EVENT REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA LOG FILES REVEALED SEVERAL POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). INVESTIGATION IS ONGOING. ADDITIONAL PRODUCTS: BATTERY/ (B)(4). D10: YES, RETURN DATE: 2018-02-20 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF DATA LOG FILES REVEALED PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING THE BATTERY. AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY/ (B)(4). D10: YES, RETURN DATE: 2018-02-20 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213, 131 H6 FDA CONCLUSION CODE(S): 12, 23 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING. THE SUPPLEMENTAL TESTING REVEALED CORROSION INSIDE THE BATTERY. ANALYSIS OF DATA LOG FILES DID NOT REVEAL ANY POWER SWITCHING EVENT INVOLVING THE BATTERY. AS A RESULT, THE REPORTED POWER SWITCHING EVENT COULD NOT BE CONFIRMED. INVESTIGATION IS ONGOING. BATTERY/ (B)(4). D10: YES, RETURN DATE: 2018-02-20 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF DATA LOG FILES REVEALED PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING THE BATTERY. AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. INVESTIGATION IS ONGOING. BATTERY/ (B)(4). D10: YES, RETURN DATE: 2018-02-20 H3: YES H6 FDA METHOD CODE(S): 10, 4112 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 12 PRODUCT EVENT SUMMARY: THE RETURNED BATTERY PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. ANALYSIS OF DATA LOG FILES REVEALED PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING THE BATTERY. AS A RESULT, THE REPORTED POWER SWITCHING EVENT WAS CONFIRMED. INVESTIGATION IS ONGOING. 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: THE CONTROLLER ((B)(4)) AND FOUR BATTERIES ((B)(4)) 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 (B)(4) REVEALED THAT THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER (B)(4) REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF THE CONTROLLER UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND POWER PORT TWO (2). AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS ARE NOT RELATED TO THE REPORTED EVENT. BASED ON AN INTERNAL INVESTIGATION, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. FAILURE ANALYSIS OF BATTERY (B)(4) REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION. SUPPLEMENTAL TESTING REVEALED CORROSION INSIDE THE BATTERY. THIS IS AN ADDITIONAL FINDING UNRELATED TO THE REPORTED EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION OF (B)(4) CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. A POSSIBLE ROOT CAUSE OF THE CORROSION FOUND INSIDE (B)(4) MAY BE ATTRIBUTED TO A PERFORATED CELL DUE TO A MANUFACTURING ASSEMBLY ERROR. AN INTERNAL INVESTIGATION EVALUATED PERFORATED CELLS DURING THE WELDING PROCESS. THE LOG FILES OF THE CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(4), REVEALED THAT THE CONTROLLER CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15 MINUTE INTERVAL. ANALYSIS OF DATA LOG FILES REVEALED SEVERAL POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). LOG FILE ANALYSIS DID NOT REVEAL ANY PREMATURE POWER SWITCHING EVENTS INVOLVING (B)(4), HOWEVER TWO (2) MOMENTARY DISCONNECTIONS WERE FOUND INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER SWITCHING EVENTS AND INTERMITTENT CONNECTION OF POWER SOURCES CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION IS OPEN TO EVALUATE MOMENTARY DISCONNECTIONS. ADDITIONAL PRODUCTS: BATTERY (B)(4). 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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY/ (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2018-05-31, UDI #: UNK, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2018-05-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY/ (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2015-12-31, UDI #: UNK, NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; MFG DATE: 2014-12-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2015-12-31, UDI #: UNK, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2014-12-31, (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, BATTERY/ (B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2015-12-31, UDI #: UNK, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2014-12-31, (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 AND BATTERIES EXHIBITED POWER SWITCHING DESPITE BATTERY CAPACITY GREATER THAN TWENTY-FIVE PERCENT (25%). IT WAS NOTED THAT WHEN THE POWER SOURCE WAS CONNECTED TO POWER PORT TWO OF THE CONTROLLER, THE POWER SOURCE WOULD INTERMITTENTLY LOSE CONNECTION WITHOUT MANIPULATION OF THE CABLE OR CONNECTOR. THE CONTROLLER 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
    116653 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420-MCS

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR MCS UNKNOWN VAD