BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7158060 · Received January 2, 2018

    Report

    Report Number
    3007042319-2018-00027
    Event Type
    Malfunction
    Date Received
    January 2, 2018
    Report Date
    April 28, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1336-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: THE DEVICES (B)(4) WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED A BENT PIN ON POWER PORT (1) OF THE CONTROLLER. THE BENT PIN DID NOT ALLOW A BATTERY TO PROPERLY CONNECT TO A CONTROLLER. A VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND POWER PORT TWO (2). AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK(S) IS/ARE NOT RELATED TO THE REPORTED EVENT. AN INTERNAL INVESTIGATION EVALUATED THE ROOT CAUSE OF THE HAIRLINE CRACK(S) AND DETERMINED IT TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENT STRESS CRACKING. FAILURE ANALYSIS OF THE RETURNED BATTERIES AND CONTROLLER AC ADAPTER (CAC) REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING. HOWEVER, VISUAL INSPECTION REVEALED THAT ALL BATTERIES AND CAC ADAPTER WERE RECEIVED WITH WORN OUT CONNECTORS. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED DAMAGED CONNECTOR CAN BE ATTRIBUTED, BUT NOT LIMITED, TO WEAR AND/OR DUE TO THE HANDLING OF THE DEVICES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED BENT PINS CAN BE ATTRIBUTED TO A MISALIGNMENT/HANDLING BETWEEN THE POWER PORT AND BATTERY OUTPUT CONNECTOR. AN INTERNAL INVESTIGATION IS OPEN TO EVALUATE TO INVESTIGATE BENT/DAMAGED PINS WITH CONTROLLER 2.0. 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

    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

    CORRECTIONS: A5, D4. PRODUCT EVENT SUMMARY: THE CONTROLLER FAILED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE EVENT WAS CONFIRMED AT THE BENCH LEVEL FOR THE CONTROLLER. THE BATTERIES AND CONTROLLER AC (CAC) ADAPTER FAILED EXTERNAL VISUAL INSPECTION BUT PASSED FUNCTIONAL TESTING. INVESTIGATION IS ONGOING. ADDITIONAL PRODUCTS: BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 BATTERY B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 CONTROLLER AC (CAC) ADAPTER (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 38 H6 FDA RESULTS CODE(S): 180 H6 FDA CONCLUSION CODE(S): 77 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 ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RECALL NUMBER. 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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2017-03-31. (B)(4). YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-03-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2017-03-31. (B)(4). YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-03-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2016-09-30. (B)(4). YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-09-30.(B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2016-01-31. (B)(4). YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2015-01-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2017-05-31. (B)(4). YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-01-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY/(B)(4)/ MODEL #: 1650DE/ EXPIRATION DATE: 2017-03-31. (B)(4). YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-03-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER. CONTROLLER AC ADAPTER /(B)(4)/UDI #: ASKU. YES, RETURN DATE: 2017-12-19. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. (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 BATTERY PINS ON THE CONTROLLER AND THE PLUGS ON THE BATTERIES AND CONTROLLER AC ADAPTER WERE DAMAGED. ALL DEVICES 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
    2529 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 1104 VAD