BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 12139741 · Received July 8, 2021

    Report

    Report Number
    2916596-2021-03358
    Event Type
    Injury
    Date Received
    July 8, 2021
    Date of Event
    June 3, 2021
    Report Date
    September 27, 2021
    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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: REVIEW OF THE SUBMITTED LOG FILES CONFIRMED LOW FLOW ALARMS. A DIRECT CORRELATION BETWEEN HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND THE REPORTED EVENTS COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2021. THE PATIENT WAS SEPTIC AND HAD MULTIPLE LOW FLOW ALARMS. THE PATIENT HAD BEEN GIVEN PLENTY OF FLUID, BUT HIS FLOWS CONTINUED TO HOVER AROUND 2.4 L/MIN. THE BEDSIDE NURSE REQUESTED INFORMATION ON HOW TO REDUCE THE LOW FLOW THRESHOLD, BUT THEY WERE INFORMED THAT WAS NOT POSSIBLE WITHOUT CHANGING THE SOFTWARE AND A PHYSICIANS APPROVAL. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) DONE ON (B)(6) 2021 WHICH SHOWED A POTENTIAL OUTFLOW GRAFT OCCLUSION; HOWEVER, NO CT SCANS WERE PROVIDED BY THE ACCOUNT. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LAB BUT NO OCCLUSION WAS OBSERVED AND THE OUTFLOW GRAFT APPEARED TO BE OPEN AND PATENT. NO STENT WAS PLACED, AND THE TEAM WILL REASSESS AND MONITOR THE PATIENT. AN UPDATE WAS COMMUNICATED ON (B)(6) 2021 THROUGH CS-152295 REPORTING THAT THE FLOWS WERE NOW RUNNING IN THE 2.8S L/MIN. THE PATIENT HAD TO BE REINTUBATED DUE TO ASPIRATION. IT WAS REPORTED ON (B)(6) 2021 THAT THE PATIENT WAS EXTUBATED AND STILL EXPERIENCING LOW FLOWS. THE FIRST SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED 33 LOW FLOW HAZARD ALARMS ALONG WITH TRANSIENT LOW FLOW EVENTS THROUGHOUT THE COURSE OF THE LOG FILE. NO OTHER ATYPICAL EVENTS OR ALARMS WERE CAPTURED. THE SYSTEM APPEARED TO OPERATE AS INTENDED AT THE SET SPEED FOR THE DURATION OF THE FILE. THE SECOND SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED 18 LOW FLOW HAZARD ALARMS ALONG WITH TRANSIENT LOW FLOW EVENTS THROUGHOUT THE COURSE OF THE LOG FILE. NO OTHER ATYPICAL EVENTS OR ALARMS WERE CAPTURED. THE SYSTEM APPEARED TO OPERATE AS INTENDED AT THE SET SPEED FOR THE DURATION OF THE FILE. THE THIRD SUBMITTED CONTROLLER EVENT LOG FILE CAPTURED 16 LOW FLOW HAZARD ALARMS ALONG WITH TRANSIENT LOW FLOW EVENTS THROUGHOUT THE COURSE OF THE LOG FILE. IN ADDITION, TRANSIENT LOW SPEED ADVISORIES WERE CAPTURED STARTING ON (B)(6) 2021 DUE TO THE STORED PATIENT SPEED BEING SET LOWER THAN THE LOW SPEED LIMIT. NO OTHER ATYPICAL EVENTS OR ALARMS WERE CAPTURED. THE SYSTEM APPEARED TO OPERATE AS INTENDED AT THE SET SPEED FOR THE DURATION OF THE FILE. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM THE CUSTOMER REGARDING THE EVENT; HOWEVER, NO ADDITIONAL INFORMATION WAS PROVIDED. THE PATIENT REMAINED ONGOING ON HEARTMATE (HM) 3 LEFT VENTRICULAR ASSIST SYSTEM (LVAS), SERIAL NUMBER (B)(6), AND NO FURTHER EVENTS HAVE BEEN REPORTED. THE HM3 LVAS IFU STATES THAT THE LOW FLOW HAZARD ALARM WILL BE TRIGGERED WHEN PUMP FLOW IS LESS THAN 2.5 LPM AND EXPLAINS THAT CHANGES IN PATIENT CONDITIONS CAN RESULT IN LOW FLOW. ADDITIONALLY, THE HM3 IFU AND PATIENT HANDBOOK DESCRIBE ALL ALARM CONDITIONS AS WELL AS THE APPROPRIATE ACTIONS ASSOCIATED WITH THEM. THE HM3 LVAS IFU LISTS SEPSIS AND RESPIRATORY FAILURE AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. THE RELEVANT SECTIONS OF THE DEVICE HISTORY RECORDS FOR (B)(6) WERE REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE TRANSIENT LOW SPEED ADVISORIES ON (B)(6) 2021, (B)(6) 2021, AND (B)(6) 2021 WERE DUE TO THE PUMP SET SPEED BEING LOWER THE LOW SPEED LIMIT.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED ON (B)(6) 2021. THE PATIENT WAS SEPTIC AND WAS HAVING CONTINUOUS LOW FLOW ALARMS. THE PATIENT HAD BEEN GIVEN PLENTY OF FLUID BUT HIS FLOWS CONTINUED TO HOVER AROUND 2.4 L/MIN. THE PATIENT HAD A COMPUTED TOMOGRAPHY (CT) DONE ON (B)(6) 2021 WHICH SHOWED AN OUTFLOW GRAFT OCCLUSION. THE PATIENT WAS TAKEN TO THE CATHETERIZATION LAB BUT NO OCCLUSION WAS OBSERVED. THE PATIENT'S LOG FILES INDICATED LOW FLOW ALARMS ON (B)(6) 2021. THE PATIENT HAD TO BE REINTUBATED DUE TO ASPIRATION. ON (B)(6) 2021 STARTING AT 16:08:58 THE PUMP'S FLOW APPEARS TO HAVE RECOVERED ABOVE 2.5 LPM. UPON REVIEW OF THE LOG FILES AFTER THE PATIENT WAS EXTUBATED THERE WERE CONTINUED LOW FLOW ALARMS AS WELL AS LOW SPEED ADVISORIES ON (B)(6) 2021, (B)(6) 2021 AND (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030056 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 6838333 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Hospitalization