BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER

    MDR report key: 8781382 · Received July 11, 2019

    Report

    Report Number
    3007042319-2019-07644
    Event Type
    Injury
    Date Received
    July 11, 2019
    Date of Event
    March 21, 2019
    Report Date
    April 26, 2022
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000420
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR CORRECTIONS. B1 WAS CORRECTED FROM PRODUCT PROBLEM TO ADVERSE EVENT & PRODUCT PROBLEM. B2 WAS CORRECTED TO HOSPITALIZATION. H1 WAS CORRECTED FROM MALFUNCTION TO SERIOUS INJURY. H6 IMF CODE WAS CORRECTED FROM F26 TO F08. H10 WAS CORRECTED TO CORRECT THE IMF CODE FROM F26 TO F08 FOR THE SYSTEM REPORTED DEVICES. D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 D4: SERIAL # (B)(6) H6: IMF CODE(S): F08 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

    REGULATORY REPORT:246151319 G4: 2019-08-14, AWARE DATE: 2019-08-14 DUE DATE: 2019-09-14 PRODUCT EVENT SUMMARY: THE CONTROLLER WAS RETURNED FOR EVALUATION. SEVEN BATTERIES, TWO CONTROLLER AC ADAPTERS AND ONE CONTROLLER DC ADAPTER WERE NOT RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE DEVICE REVEALED THAT THE CONTROLLER PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH CONTROLLER POWER PORTS. ADDITIONALLY, VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK AROUND POWER PORT TWO (2). AN INTERNAL VISUAL INSPECTION DID NOT REVEAL ANY EVIDENCE OF FLUID INGRESS. THESE ARE ADDITIONAL FINDINGS UNRELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE CONTAMINATION WITHIN THE POWER PORTS CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. INTERNAL INVESTIGATION WAS OPENED AND 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 ENVIRONMENT STRESS CRACKING. LOG FILES ANALYSIS 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 THE DATA LOG FILES REVEALED SEVERAL TRANSIENT MOMENTARY DISCONNECTION EVENTS AND SEVERAL PREMATURE POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING SEVEN BATTERIES. DATA LOG FILES ALSO REVEALED SEVERAL TRANSIENT MOMENTARY DISCONNECTIONS INVOLVING A POWER ADAPTER WITHIN THE ANALYZED PERIOD. MOMENTARY DISCONNECTIONS RESULT IN AN AUDIBLE TONE OR "BEEP." ANALYSIS OF THE EVENT LOG FILES REVEALED SEVERAL CONTROLLER POWER-UP EVENTS LOGGED SINCE 21/MAY/2019 LEADING UP TO 17/JUN/2019. SEVERAL MOMENTARY DISCONNECTIONS WERE OBSERVED LEADING UP TO THE VARIOUS LOSSES OF POWER. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENTS AND ¿BEEPS¿ CAN BE ATTRIBUTED TO AN INTERMITTENT CONNECTION AS A RESULT OF THE CONTAMINATION OF THE CONTROLLER POWER PORTS AND/OR MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. INTERNAL INVESTIGATING WAS INITIATED TO CAPTURE MOMENTARY DISCONNECTIONS. INTERNAL INVESTIGATION WAS INITIATED TO CAPTURE EVENTS INVOLVING THE CONTROLLER LOSING POWER. ADDITIONAL PRODUCTS: D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S): 4112,4114 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S): 3213 H6: FDA CONCLUSION CODE(S): 12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 D4: SERIAL # (B)(6) H6: FDA METHOD CODE(S):4112,4114 H6: FDA RESULTS CODE(S):3213 H6: FDA CONCLUSION CODE(S):12 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

    OTHER DEVICES INVOLVED IN THIS EVENT: 1650 /(B)(4) /MODEL #:1650/EXPIRATION DATE: UNKNOWN. 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, 1425US / (B)(4) /MODEL #:1425/EXPIRATION DATE: UNKNOWN, UDI #:ASKU. DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, 1425US / (B)(4) /MODEL #:1425/EXPIRATION DATE: UNKNOWN. UDI #: ASKU. DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER, 1435- /(B)(4)/MODEL #:1435/ EXPIRATION DATE: UNKNOWN, UDI #:(B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650- / (B)(4)/MODEL #:1650/EXPIRATION DATE: 2016-10-31, UDI #:(B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: 2015-10-31. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650- / (B)(4)/MODEL #:1650/EXPIRATION DATE: 2016-11-30, UDI #:(B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: 2015-11-30. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650-/(B)(4)/MODEL #:1650/EXPIRATION DATE: 2016-11-30, UDI #:(B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: 2015-11-30. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650 /(B)(4)/MODEL #:1650/EXPIRATION DATE: 2017-03-31, UDI #:(B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: 2016-03-31. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650 /(B)(4)/MODEL #:1650/EXPIRATION DATE: UNKNOWN, UDI #:ASKU. DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650 / (B)(4)/MODEL #:1650/EXPIRATION DATE: 2016-11-30, UDI #: (B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: 2015-11-30. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, 1650 /(B)(4)/MODEL #:1650/EXPIRATION DATE: 2016-11-30, UDI #:(B)(4). DEVICE AVAILABLE FOR EVAL: NO. MFG DATE: 2015-11-30. LABELED FOR SINGLE USE: NO. (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 HAD INTERMITTENT POWER SOURCE SWITCHING WITH BEEPS HEARD. REVIEW OF LOG FILES REVEALED CONTROLLER POWER-UP AND ASSOCIATED PUMP START EVENTS, INDICATING A LOSS OF POWER TO THE CONTROLLER. ALL OF THE POWER SOURCES WERE SERVICED WITH LUBRICANT. THE PATIENT WAS HOSPITALIZED AS A RESULT OF THIS EVENT. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573591 HEARTWARE® VENTRICULAR ASSIST SYSTEM - CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420-CONTROLLER 00888707000420

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Female Hospitalization HVAD 1103