BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6247189 · Received January 12, 2017

    Report

    Report Number
    3007042319-2017-00116
    Event Type
    Malfunction
    Date Received
    January 12, 2017
    Date of Event
    December 12, 2016
    Report Date
    November 16, 2017
    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

    DRIVELINE EXTENSION CABLE WITH LOT#1212200 WAS NOT RETURNED FOR EVALUATION; (B)(4) WAS RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DRIVELINE EXTENSION CABLE MET ALL REQUIREMENTS FOR RELEASE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE DEVICE PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE ANALYSIS OF THE CONTROLLER DID NOT REVEAL ANY ANOMALIES AND THE DRIVELINE EXTENSION CABLE WAS NOT RETURNED FOR ANALYSIS. THERE IS NO EVIDENCE TO SUGGEST THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE RISK DOCUMENTATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO DIFFICULTY ENGAGING ELECTRICAL CONTACTS BETWEEN CONTACT BLOCK AND RECEPTACLE, INSECURE JUNCTION BETWEEN CONTROLLER AND DRIVELINE EXTENSION CABLE, RECESSED PINS. 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 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 (IFU) SYSTEM OUTLINES PROPER USAGE OF THE DRIVELINE EXTENSION CABLE. THE DRIVELINE EXTENSION CABLE SHOULD BE USED ONLY DURING THE PRE-IMPLANT WET TEST TO KEEP THE NON-STERILE CONTROLLER ISOLATED FROM THE STERILE FIELD. THE DRIVELINE EXTENSION CABLE IS NOT INTENDED TO BE USED AFTER THE PUMP IS IMPLANTED IN THE PATIENT. IN ADDITION, THE IFU PROVIDES GUIDELINES TO HELP THE USER TO DETECT AND REACT TO THE HVAD PUMP STOPPING AND UNSUCCESSFULLY RESTARTING. MOREOVER, HEARTWARE CLINICAL OPERATOR TRAINING FURTHER EDUCATES HEALTHCARE PRACTITIONERS ABOUT PRODUCT SAFETY, ALARM MANAGEMENT, AND HVAD SUPPORT. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PERFUSIONIST THAT IT WAS NOT POSSIBLE TO CONNECT THE DRIVELINE EXTENSION CABLE TO THE CONTROLLER. THE PERFUSIONIST STATED THAT "IT SEEMED, THERE WAS A MECHANICAL BLOCKAGE ". THERE WERE NO REPORTED ISSUES REGARDING THE DRIVELINE EXTENSION CABLE OR CONTROLLER PRIOR TO IMPLANT. THE DRIVELINE EXTENSION CABLE WAS REMOVED FROM USE WITH NO SIGNIFICANT PROCEDURAL DELAYS OR PATIENT COMPLICATIONS. THERE HAVE NOT BEEN SUBSEQUENT CONNECTION ISSUES SINCE THE IMPLANT PROCEDURE. THE SECOND EXTENSION CABLE UTILIZED WAS CONNECTED SUCCESSFULLY, THUS RESOLVING THE ISSUE. IT WAS REPORTED BY THE PERFUSIONIST THAT IT WAS NOT POSSIBLE TO CONNECT THE DRIVELINE EXTENSION CABLE TO THE CONTROLLER. THE PERFUSIONIST STATED THAT "IT SEEMED, THERE WAS A MECHANICAL BLOCKAGE ". THE DRIVELINE EXTENSION CABLE WAS REMOVED FROM USE. THE SECOND EXTENSION CABLE USED WAS USED ABLE TO CONNECT SUCCESSFULLY. NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE PERFUSIONIST THAT IT WAS NOT POSSIBLE TO CONNECT THE DRIVELINE EXTENSION CABLE TO THE CONTROLLER.  THE PERFUSIONIST STATED THAT "IT SEEMED, THERE WAS A MECHANICAL BLOCKAGE." THERE WERE NO REPORTED ISSUES REGARDING THE DRIVELINE EXTENSION CABLE OR CONTROLLER PRIOR TO IMPLANT. THE DRIVELINE EXTENSION CABLE WAS REMOVED FROM USE WITH NO SIGNIFICANT PROCEDURAL DELAYS OR PATIENT COMPLICATIONS. THERE HAVE NOT BEEN SUBSEQUENT CONNECTION ISSUES SINCE THE IMPLANT PROCEDURE.  THE SECOND EXTENSION CABLE UTILIZED WAS CONNECTED SUCCESSFULLY, THUS RESOLVING THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29839 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM, PRODUCT CODE, PRODUCT CODE DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization CONTROLLER/(B)(4)