BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP

    MDR report key: 6523229 · Received April 26, 2017

    Report

    Report Number
    3007042319-2017-01279
    Event Type
    Injury
    Date Received
    April 26, 2017
    Date of Event
    March 30, 2017
    Report Date
    March 30, 2017
    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

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. (B)(4) WAS NOT RETURNED TO HEARTWARE FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES WHICH REVEALED AN INCREASE IN POWER CONSUMPTION STARTING (B)(6) 2017 TO A PEAK OF 6.1 WATTS ON (B)(6) 2017 OUTSIDE NORMAL OPERATING RANGE. PARAMETERS RETURNED TO NORMAL ON (B)(6) 2017. NO ALARMS WERE LOGGED FOR THE PAST 14 DAYS LEADING UP TO (B)(6) 2017. OF NOTE, IT WAS REPORTED THAT THE PATIENT RECEIVED ACTILYSE TREATMENT AFTER WHICH LDH LEVELS DECREASED. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE HIGH-POWER EVENT CAN BE ATTRIBUTED TO EXTERNAL FACTORS SUCH AS THROMBUS FORMATION/INGESTION. BASED ON THE AVAILABLE INFORMATION CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT INCLUDE POSSIBLE ISSUES WITH THE MANAGEMENT OF THE PATIENT'S THERAPEUTIC ANTICOAGULATION AND ANTIPLATELET MEDICATIONS AS WELL AS THE PATIENT'S RELATED COMORBIDITIES. ALTHOUGH THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED, THERE ARE PATIENT AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. AFTER FURTHER REVIEW OF INFORMATION THE FOLLOWING SECTIONS HAVE BEEN CORRECTED ACCORDINGLY: (INADVERTELY PLACED ON FOLLOW-UP 1). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED FROM THE SITE, THAT THE PATIENT WAS IDENTIFIED AS HAVING THROMBUS BY ACCESSING THE LOGFILES, BY ECHO REPORT AHD HEMOLYSIS LABS WITH LDH AND FHB WITH POSITIVE MARKERS FOR THROMBUS. IT WAS REPORTED THAT THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2017. IT WAS FURTHER STATED THAT THERE WAS NO ADDITIONAL INFORMATION AVAILABLE AT THIS TIME. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    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 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. HIGH WATTS ALARMS, AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP. THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. DEVICE REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE 02.03. INR: 1,52. 29.03. INR: 2.45. 02.03. LDH: 245. 29.03. LDH: 2124. 02.03. HAPTOGLOBIN: 1,07. 29.03. HAPTOGLOBIN: <0,10. STABLE WITH DECREASING LDH. RPM 2800 FLOW 4,9 WATT 4,8.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE SITE THAT THE PATIENT CAME INTO THE HOSPITAL WITH RED COLORED URINE, AN INCREASE OF LACTATE DEHYDROGENASE (LDH) TO 2100, AND WATT INCREASE OF UP TO 6 WATT. IT WAS STATED THAT THE CLINIC INITIALED START OF LYSIS WITH 10MG OF ACTILYSE. POST LYSIS THERE WAS A DECREASE OF THE LDH IN THE LABORATORY VALUES. BUT AFTER A SHORT WHILE THERE WAS A SECOND INCREASE OF THE LDH AND LYSIS WAS RESTARTED A SECOND TIME AND WAS STILL RUNNING AT TIME OF THIS REPORT. IT WAS STATED THAT THE PATIENT WAS DOING WELL THROUGHOUT THE PROCESS AND THERE WERE NO ALARMS AND NO PUMP STOPS ASSOCIATED WITH THE EVENT. IT WAS ALSO STATED THAT THERE WERE NO SYMPTOMS OF ISCHEMIA OR BLEEDING WHILE LYSIS THERAPY. NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303983 HEARTWARE® VENTRICULAR ASSIST SYSTEM - PUMP CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| L| R