BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5334962 · Received December 30, 2015

    Report

    Report Number
    3007042319-2015-04208
    Event Type
    Malfunction
    Date Received
    December 30, 2015
    Date of Event
    December 11, 2015
    Report Date
    December 11, 2015
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1917-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION: BATTERY: (B)(4) - EXPIRATION DATE: 01-31-20216, MFR -01-16-2015, UDI # (B)(4). BATTERY: (B)(4) - EXPIRATION DATE: 04-30-20216, MFR -04-24-2015, UDI # (B)(4). ONE CONTROLLER AND THREE BATTERIES WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. ANALYSIS OF THE DEVICES REVEALED THAT THE DEVICES MET SPECIFICATIONS; THE DEVICES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. THE POOR MECHANICAL CONNECTION ON THE CONTROLLER WAS NOT CONFIRMED; THERE WERE NO EXTERNAL ABNORMALITIES NOTED ON THE DRIVELINE CONNECTORS OR POWER SOURCE CONNECTORS. THE REPORTED POWER SWITCHING WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED SEVERAL OCCURRENCES OF PREMATURE POWER SWITCHING PRIOR TO THE 25% THRESHOLD INVOLVING BATTERY SERIALS (B)(4). THESE PREMATURE SWITCHING EVENTS WERE MOST LIKELY CAUSED BY A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND BATTERIES. HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION TO EVALUATE THESE TYPES OF ISSUES. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND THE BATTERIES. ADDITIONAL SYSTEM COMPONENT BEING REPORTED FOR THIS EVENT: CONTROLLER: (B)(4) - EXPIRATION -03-31-2016, MFR -03-01-2015. BATTERY: (B)(4) - EXPIRATION DATE: 02-29-20216, MFR -02-03-2015. THIS IS THREE OF THREE REPORTS (3007042319-2015-04206, 3007042319-2015-04207 AND 3007042319-2015-04208) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. 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. THE INSTRUCTIONS FOR USE AND PATIENT MANUAL INCLUDE A WARNING TO KEEP A SPARE BACK UP CONTROLLER AVAILABLE AT ALL TIMES AND OUTLINES THAT IF THERE IS A CONTROLLER FAILURE, THE CONTROLLER SHOULD BE SWITCHED TO THE BACK-UP CONTROLLER. THE STEPS FOR EXCHANGE OF DEVICES ARE ALSO OUTLINED. IT FURTHER WARNS THAT DAMAGED EQUIPMENT SHOULD BE REPORTED TO THE MANUFACTURER AND INSPECTED. THE INSTRUCTIONS FOR USE (IFU) PROVIDES INSTRUCTIONS FOR PROPERLY CONNECTING THE POWER SOURCES. IT INSTRUCTS TO LINE UP THE SOLID WHITE ARROW ON THE CONNECTOR WITH THE WHITE DOT ON THE CONTROLLER. GENTLY PUSH THE CABLE INTO THE CONTROLLER. DO NOT TWIST THE CONNECTOR, BUT ALLOW IT TO NATURALLY LOCK IN PLACE. A SUCCESSFUL CONNECTION WILL RESULT IN AN AUDIBLE CLICK. THE IFU CAUTIONS, "DO NOT FORCE CONNECTORS TOGETHER WITHOUT PROPER ALIGNMENT. FORCING TOGETHER MISALIGNED CONNECTORS MAY DAMAGE THE CONNECTORS." HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. THIS IS THREE OF THREE REPORTS (3007042319-2015-04206, 3007042319-2015-04207 AND 3007042319-2015-04208) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4) WERE NOT RETURNED FOR ANALYSIS, AND COULD NOT BE TESTED AT THE BENCH; HOWEVER, THE LOGS SHOW SUFFICIENT EVIDENCE TO SUGGEST A COMMUNICATION MALFUNCTION BETWEEN CONTROLLER AND THE BATTERIES OR A USE PATTERN THAT COULD HAVE CONTRIBUTED TO THE PREMATURE SWITCHING OBSERVED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO A COMMUNICATION ERROR BETWEEN THE CONTROLLER AND THE BATTERIES, WHICH LIKELY CONTRIBUTED TO THE EVENT. (B)(4) (WAS NOT RETURNED). (B)(4) (WAS NOT RETURNED). HEARTWARE HAS OPENED AN INTERNAL INVESTIGATION UNDER TO EVALUATE THESE TYPES OF ISSUES. THIS IS THREE OF THREE REPORTS (3007042319-2015-04206, 3007042319-2015-04207 AND 3007042319-2015-04208) SUBMITTED FOR DEVICES RELATED TO THE SAME EVENT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PATIENT EXPERIENCED SWITCHING ALWAYS ON PORT 1 OF THE CONTROLLER. THE CONTROLLER AND BATTERIES WERE EXCHANGED WITH NO EFFECT ON THE PATIENT. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    858498 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR