BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 6483317 · Received April 11, 2017

    Report

    Report Number
    3007042319-2017-04142
    Event Type
    Death
    Date Received
    April 11, 2017
    Date of Event
    September 11, 2017
    Report Date
    March 30, 2018
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    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: 2017-06-30 UDI #: (B)(4). DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-06-30. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY; BATTERY /(B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-11-30 UDI #: (B)(4). RETURN DATE: 2017-11-13. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2016-11-30. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2017-10-31 UDI #: (B)(4). RETURN DATE: 2017-11-13. NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN .MFG DATE: 2016-10-31. BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY;BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2018-01-31 UDI #: (B)(4). RETURN DATE: 2017-11-13.DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-01-31. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-01-31 UDI #: (B)(4). YES, RETURN DATE: 2017-11-13. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-01-31. HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY. BATTERY / (B)(4) / MODEL #: 1650DE / EXPIRATION DATE: 2018-02-28 UDI #: (B)(4). RETURN DATE: 2017-11-13. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN. MFG DATE: 2017-02-28. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    (B)(4) WAS RETURNED TO HEARTWARE FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS ANALYSIS IS SOLELY TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE AGAINST CURRENT MANUFACTURING/DESIGN SPECIFICATIONS AND/OR TO IDENTIFY ANY ANOMALIES INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE PASSED DIMENSIONAL VERIFICATION. VISUAL EXAMINATION REVEALED MILD ABRASIONS ON THE LOWER HOUSING CERAMIC SURFACE AND INFERIOR SURFACE OF THE IMPELLER. FUNCTIONAL TESTING REVEALED A POWER SHIFT CONDITION WITH A MAXIMUM POWER ATTAINED BY THE SHIFT OF 2.18 W. THIS POWER SHIFT CONDITION WAS NOT PRESENT AT THE TIME OF PUMP RELEASE AND CONSIDERING THAT THE RETURNED DEVICE PASSED POWER CONSUMPTION REQUIREMENTS, THIS DEVIATION WAS LIKELY INTRODUCED DURING USE AND COULD BE ASSOCIATED WITH THE ABRASION MARKS NOTED ON THE IMPELLER'S SURFACE. THE ABRASION MARKS MAY CAUSE A SLIGHT IMBALANCE OF THE IMPELLER THUS LEADING TO A TEMPORARY INCREASE IN POWER CONSUMPTION OR POWER SHIFT. LOG FILE ANALYSIS REVEALED NORMAL POWER CONSUMPTION AND NO ALARMS LOGGED FOR THE PAST 14 DAYS UNTIL (B)(6) 2016. OF NOTE, THE MEDICAL STAFF DID NOT BELIEVE THAT THE DEATH WAS RELATED TO THE DEVICE. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE OF ANY MALFUNCTION THAT COULD HAVE PREVENTED THE PUMP FROM FUNCTIONING AS INTENDED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THE FOLLOWING CORRECTIONS: (DATE FDA RECEIVED, FOR INITIAL REPORT) = (B)(4) 2017, (CATALOG #) = 1420 G4, (INITIAL REPORT) = (B)(6) 2017, MALFUNCTION . PLEASE REMOVE THE FOLLOWING NARRATIVE TEXT (IN QUOTES), WHICH WAS INADVERTENTLY PLACED INTO THIS REPORT, AND WHICH IS PROPERLY FOUND IN REPORT 3007042319-2016-04142: "(B)(4) WAS RETURNED TO HEARTWARE FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS ANALYSIS IS SOLELY TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICE AGAINST CURRENT MANUFACTURING/DESIGN SPECIFICATIONS AND/OR TO IDENTIFY ANY ANOMALIES INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE PUMP FROM PERFORMING AS INTENDED. ANALYSIS OF THE DEVICE REVEALED THAT THE DEVICE PASSED DIMENSIONAL VERIFICATION. VISUAL EXAMINATION REVEALED MILD ABRASIONS ON THE LOWER HOUSING CERAMIC SURFACE AND INFERIOR SURFACE OF THE IMPELLER. FUNCTIONAL TESTING REVEALED A POWER SHIFT CONDITION WITH A MAXIMUM POWER ATTAINED BY THE SHIFT OF 2. 18 W. THIS POWER SHIFT CONDITION WAS NOT PRESENT AT THE TIME OF PUMP RELEASE AND CONSIDERING THAT THE RETURNED DEVICE PASSED POWER CONSUMPTION REQUIREMENTS, THIS DEVIATION WAS LIKELY INTRODUCED DURING USE AND COULD BE ASSOCIATED WITH THE ABRASION MARKS NOTED ON THE IMPELLER'S SURFACE. THE ABRASION MARKS MAY CAUSE A SLIGHT IMBALANCE OF THE IMPELLER THUS LEADING TO A TEMPORARY INCREASE IN POWER CONSUMPTION OR POWER SHIFT. LOG FILE ANALYSIS REVEALED NORMAL POWER CONSUMPTION AND NO ALARMS LOGGED FOR THE PAST 14 DAYS UNTIL (B)(6) 2016. OF NOTE, THE MEDICAL STAFF DID NOT BELIEVE THAT THE DEATH WAS RELATED TO THE DEVICE. BASED ON THE INVESTIGATION CONDUCTED, THERE IS NO EVIDENCE OF ANY MALFUNCTION THAT COULD HAVE PREVENTED THE PUMP FROM FUNCTIONING AS INTENDED. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT." PRODUCT EVENT SUMMARY: IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING POWER SWITCHING. THE CONTROLLER ((B)(4)) AND SIX BATTERIES ((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 DEVICES REVEALED THAT THE CONTROLLER AND BATTERIES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA FILES REVEALED POWER SWITCHING EVENTS DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO ADDRESS MOMENTARY DISCONNECTIONS. (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 EXPERIENCED ANXIETY WHEN BATTERY SWITCHING WAS NOTED. THE CONTROLLER AND BATTERIES WERE EXCHANGED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266343 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1407DE

    Patients

    Seq Age Sex Outcome Treatment
    1