BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17762370 · Received September 17, 2023

    Report

    Report Number
    2916596-2023-06493
    Event Type
    Injury
    Date Received
    September 17, 2023
    Date of Event
    August 27, 2023
    Report Date
    November 28, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 0

    PATIENT'S PREVIOUS DRIVELINE FAULT WAS REPORTED UNDER MANUFACTURER REPORT NUMBER 2916596-2023-00066. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORT OF FLUID INGRESS INTO THE INLINE CONNECTOR DUE TO THE EXIT SITE DRAINAGE COULD NOT BE CONFIRMED THROUGH THIS EVALUATION. ADDITIONALLY, A SPECIFIC CAUSE FOR THE DRAINAGE COULD NOT BE CONCLUSIVELY DETERMINED. IT WAS REPORTED THAT THE MODULAR AND PUMP CABLE INLINE CONNECTION WAS GOING IN AND OUT OF THE PATIENT'S DRIVELINE EXIT SITE AND THE PATIENT HAD DRAINAGE INSIDE THE CONNECTION ITSELF. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN MORE INFORMATION REGARDING POTENTIAL INFECTION IN REGARD TO THE DRAINAGE; HOWEVER, NO FURTHER INFORMATION WAS PROVIDED BY THE ACCOUNT. THE SUBMITTED LOG FILES CAPTURED THE PUMP OPERATING AS INTENDED AT THE SET SPEED. THE PATIENT REMAINS ONGOING ON HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6). NO FURTHER RELATED EVENTS HAVE BEEN REPORTED AT THIS TIME. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE HEARTMATE 3 LVAS INSTRUCTIONS FOR USE (IFU), REV. C, AND HEARTMATE 3 LVAS PATIENT HANDBOOK, REV. D, ARE CURRENTLY AVAILABLE. SECTION 1 OF THE IFU, "INTRODUCTION," LISTS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LVAS. ALTHOUGH INFECTION WAS NOT REPORTED BY THE ACCOUNT, INFECTION IS ALSO LISTED AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LVAS, AS WELL AS A POTENTIAL LATE POSTIMPLANT COMPLICATION. ADDITIONALLY, SEVERAL SECTIONS OF THE IFU AND PATIENT HANDBOOK PROVIDE CARE INSTRUCTIONS IN REGARD TO PREVENTING INFECTION AS WELL AS SUGGESTED RESPONSES IN THE EVENT OF INFECTION. SECTION 7 OF THE IFU, ALARMS AND TROUBLESHOOTING,¿ AND SECTION 5 OF THE PATIENT HANDBOOK, ¿ALARMS AND TROUBLESHOOTING,¿ PROVIDE INSTRUCTIONS REGARDING HOW TO CARE FOR THE DRIVELINE IN SUB-SECTIONS ENTITLED "WHAT NOT TO DO: DRIVELINE AND CABLES." SECTION 8 OF THE IFU, ¿EQUIPMENT STORAGE AND CARE,¿ CONTAINS DRIVELINE CARE INSTRUCTIONS AND EXPLAINS THAT THE EXTERIOR SURFACES OF THE DRIVELINE CABLES CAN BE CLEANED WITH A DAMP, LINT-FREE CLOTH AS NEEDED. IF MORE AGGRESSIVE CLEANING IS NEEDED, IT IS RECOMMENDED TO USE WARM WATER AND MILD DISH SOAP. SECTION 4 OF THE PATIENT HANDBOOK, ¿LIVING WITH THE HEARTMATE 3,¿ CONTAINS ADDITIONAL INFORMATION ON CARING FOR THE DRIVELINE AND INSTRUCTS THE PATIENT TO KEEP THE DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME AND IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT WAS ADMITTED WITH DRIVELINE POWER FAULT. FLUOROSCOPY MIGHT BE PERFORMED TO LOOK AT THE INTERNAL DRIVELINE. LOG FILES CAPTURED ON (B)(6) 2023, DRIVE LINE POWER FAULT ALARMS. CONTROLLER AND MODULAR CABLE WERE EXCHANGED. THE ALARMS CLEARED. THE MODULAR CABLE CONNECTION WAS STILL GOING IN AND OUT OF PATIENT'S DRIVELINE EXIT SITE. THEY HAD DRAINAGE INSIDE THE CONNECTION ITSELF. RELATED CONTROLLER IS REPORTED UNDER MFR# 2916596-2023-06494. RELATED MODULAR CABLE IS REPORTED UNDER MFR# 2916596-2023-06495. PREVIOUS DRIVELINE COMMUNICATION FAULT WAS REPORTED UNDER MFR# PER-2022-0201860.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1040322 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8432829 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR Female Other