BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 6820235 · Received August 25, 2017

    Report

    Report Number
    3007042319-2017-02852
    Event Type
    Injury
    Date Received
    August 25, 2017
    Date of Event
    July 4, 2017
    Report Date
    October 16, 2018
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER PRODUCTS INVOLVED IN THIS EVENT: (B)(4)- CONTROLLER / CATALOG NUMBER 1420 / EXPIRATION DATE: 03/31/2018. DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE?: NO. (B)(4). UNK-BATTERY / CATALOG NUMBER / EXPIRATION DATE: DEVICE AVAILABLE FOR EVALUATION?: NO. NO, NOT RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE?: NO. (B)(4). THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THE PUMP ((B)(4)), CONTROLLER ((B)(4)), AND BATTERY OF UNKNOWN SERIAL NUMBER WERE NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING RECORDS CONFIRMED THAT THE ASSOCIATED PUMP AND CONTROLLER MET ALL REQUIREMENTS FOR RELEASE. A REVIEW OF THE MANUFACTURING RECORDS OF THE BATTERY COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER WAS NOT PROVIDED. THE REPORTED BATTERY DEPLETION EVENT WAS CONFIRMED THROUGH LOG FILE ANALYSIS. ANALYSIS OF THE ALARM LOG FILE REVEALED THAT 13 CRITICAL BATTERY 1 ALARMS, 13 CRITICAL BATTERY 2 ALARMS, AND 14 CONTROLLER FAULT ALARMS WERE LOGGED ON (B)(6) 2017 STARTING AT 05:19:19. ANALYSIS OF THE LOG FILES REVEALED THAT, AT THE TIME OF THE FIRST CRITICAL BATTERY ALARM, (B)(4) WAS CONNECTED TO POWER PORT 1 WITH 22% RELATIVE STATE OF CHARGE (RSOC) AND (B)(4) WAS CONNECTED TO POWER PORT 2 WITH 9% RSOC. BOTH BATTERIES WERE THEN ALLOWED TO DEPLETE. ONCE A BATTERY STARTS NEARING 0%, OR 12 V, THE CONTROLLER WILL TRIGGER A CONTROLLER FAULT ALARM. THE DEPLETED BATTERIES WERE NOT EXCHANGED, RESULTING IN A LOSS OF POWER TO THE CONTROLLER AT 07:57:35. THREE (3) CONTROLLER POWER UP EVENTS WERE LOGGED DURING THE REPORTED EVENT, AT 11:56:07, 12:23:53 AND 12:45:54. THE CONTROLLER WAS THEN POWERED UP WITH FULLY CHARGED BATTERIES AT 15:26:33. NO VAD STOP ALARMS WERE RECORDED; THEREFORE THIS ASPECT OF THE REPORTED EVENT COULD NOT BE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THE PATIENT ALLOWING BOTH POWER SOURCES TO DEPLETE COMPLETELY. THE DEVICE REMAINS IMPLANTED IN THE PATIENT AND IS THUS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER. WITH A REVIEW OF THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO INDICATE ANY DEVICE MALFUNCTIONS OR PERFORMANCE ISSUES THAT WOULD IMPACT THE REPORTED EVENTS. POSSIBLE CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT¿S PRE-EXISTING HISTORY AND RELATED COMORBIDITIES, THE PROGRESSION OF THEIR UNDERLYING DISEASE, ISSUES RELATED TO THE THERAPEUTIC USE OF ANTICOAGULANT AND ANTIPLATELET MEDICATIONS AND THE PATIENT'S COMPLEX POST-OPERATIVE COURSE. THERE ARE POSSIBLE PATIENT, PHARMACOLOGICAL AND PROCEDURAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE MANUFACTURER HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE EVENTS LEADING TO LOSS OF CONTROLLER POWER. CONCOMITANT MEDICAL PRODUCTS: MEDICAL DEVICE: (B)(4) - CONTROLLER / CATALOG NUMBER 1420 / EXPIRATION DATE: 2018-03-31.. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE: 2017-03-31. LABELED FOR SINGLE USE: NO. (B)(4). MEDICAL DEVICE: UNK-BATTERY / CATALOG NUMBER / EXPIRATION DATE: UNKNOWN. DEVICE AVAILABLE FOR EVALUATION: NO. DEVICE EVALUATED BY MANUFACTURER: NO, NOT RETURNED TO MANUFACTURER. DEVICE MANUFACTURE DATE: UNK. LABELED FOR SINGLE USE: NO. (B)(4). DEVICE NOT RETURNED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER DEVICES INVOLVED IN THIS EVENT: MEDICAL DEVICE: CONTROLLER / (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 WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2017 VIA AMBULANCE WITH A VENTRICULAR ASSIST DEVICE (VAD) STOP ALARM. BOTH BATTERIES WERE CONNECTED TO THE CONTROLLER, HOWEVER THE BATTERIES WERE COMPLETELY DEPLETED. THE PATIENT SHOWED SIGNS OF A NEUROLOGICAL EVENT WITH AN INTERNATIONAL NORMALIZED RATIO (INR) OF 3.0. A CRANIAL COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED WHICH SHOWED SUBARACHNOIDAL BLEEDING (SAB). IT WAS NOTED THAT THE INR HAD BEEN UP TO 10 A FEW DAYS PRIOR AND WAS THOUGHT TO BE THE REASON FOR THE SAB. IN THE COURSE OF THE NEXT FEW DAYS THE PATIENT'S CONDITION STABILIZED AND THEY ARE NOW STABLE IN THE REGULAR WARD WITH NO NEUROLOGICAL SIGNS. THE PATIENT WAS SCHEDULED TO GO TO REHABILITATION ON (B)(6) 2017. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602750 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM, DSQ HEARTWARE, INC 1104

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| L| R