BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 9242094 · Received October 25, 2019

    Report

    Report Number
    3007042319-2019-12277
    Event Type
    Malfunction
    Date Received
    October 25, 2019
    Date of Event
    October 2, 2019
    Report Date
    November 25, 2019
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000475
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: ONE CONTROLLER AND SEVEN BATTERIES WERE NOT RETURNED FOR EVALUATION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT, 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 FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO COMMUNICATION ERRORS INVOLVING ONE OF THE BATTERIES, AS WELL AS SEVERAL MOMENTARY DISCONNECTIONS THAT DID NOT LEAD TO PREMATURE POWER SWITCHING EVENTS INVOLVING THREE OTHER BATTERIES. MOMENTARY DISCONNECTION WILL RESULT IN AN AUDIBLE TONE OR ¿BEEP¿. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. ALL BATTERIES WERE RE-LUBRICATED ON 07/OCT/2019 TO MITIGATE THE REPORTED CONDITIONS. THE MOST LIKELY ROOT CAUSE OF THE PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED TO COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERY. THE MOST LIKELY ROOT CAUSE OF THE REPORTED ¿BEEPING¿ AFTER LUBRICATION CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO CORROSION OF THE CONTROLLER POWER PORT PINS. PLI20, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213, H6: FDA CONCLUSION CODE(S): 4307 PLI30, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213213, H6: FDA CONCLUSION CODE(S): 67 PLI40, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213, H6: FDA CONCLUSION CODE(S): 4307 PLI50, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213213, H6: FDA CONCLUSION CODE(S): 67 PLI60, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213213, H6: FDA CONCLUSION CODE(S): 67 PLI70, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213213, H6: FDA CONCLUSION CODE(S): 67 PLI80, H6: FDA METHOD CODE(S): 4112,4114, H6: FDA RESULTS CODE(S): 3213, H6: FDA CONCLUSION CODE(S): 4307. 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. CONCOMITANT MEDICAL PRODUCTS: DDBB1D4 ICD, 6935M62 LEAD, 5076-52 LEAD, IMPLANTED: (B)(6) 2015. ADDITIONAL PRODUCTS: PLI20 HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: 1650DE / CATALOG #: 1650DE/ EXPIRATION DATE: 2019-03-31/ SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 2018-03-31. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: UNK / CATALOG #: UNK/ EXPIRATION DATE: UNK / SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: 1650DE / CATALOG #: 1650DE/ EXPIRATION DATE: 2019-05-31/ SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 2018-05-30. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: 1650DE / CATALOG #: 1650DE/ EXPIRATION DATE: 2019-03-31/ SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 2018-03-31. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: 1650DE / CATALOG #: 1650DE/ EXPIRATION DATE: 2019-08-31/ SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 2018-08-07. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: 1650DE / CATALOG #: 1650DE/ EXPIRATION DATE: 2019-03-31/ SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 2018-03-31. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY MODEL #: 1650DE / CATALOG #: 1650DE/ EXPIRATION DATE: 2019-03-31/ SERIAL# (B)(4). UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: 2018-03-31. 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 VENTRICULAR ASSIST DEVICE (VAD) WAS POWER SWITCHING. THE PATIENT WAS HEARING A SINGLE BEEP FROM THEIR CONTROLLER INDICATING A NEW POWER SOURCE IS BEING ATTACHED. THE CONTROLLER REMAINS IN USE. THE BATTERIES WERE TREATED WITH LUBRICATION AND REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035188 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE, INC. 1420-CONTROLLER 00888707000475

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR 1103 HVAD