BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 6919336 · Received October 5, 2017

    Report

    Report Number
    2916596-2017-02239
    Event Type
    Injury
    Date Received
    October 5, 2017
    Date of Event
    August 24, 2017
    Report Date
    February 20, 2018
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FULL EVALUATION OF THE DEVICE COULD NOT BE CONDUCTED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED CLOT FORMATION COULD NOT BE CONCLUSIVELY DETERMINED. THE CENTRIMAG BLOOD PUMP IFU LISTS THROMBOEMBOLIC PHENOMENA AS POSSIBLE SIDE EFFECTS THAT MAY BE ASSOCIATED WITH THE USE OF THE CENTRIMAG BLOOD PUMP AND WARNS THE USER TO MONITOR THE CIRCUIT CAREFULLY FOR ANY SIGNS OF OCCLUSION. THIS DOCUMENT ALSO EXPLAINS THAT THE BLOOD PUMP IS INTENDED TO BE USED WITH SYSTEMIC ANTICOAGULATION AND INSTRUCTS THE USER TO ALWAYS HAVE A SPARE CENTRIMAG BLOOD PUMP, BACK-UP CONSOLE, AND EQUIPMENT AVAILABLE FOR CHANGE OUT. A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED AS THE SERIAL NUMBER OF THE DEVICE WAS NOT PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE, GENDER AND WEIGHT WERE NOT PROVIDED. CONCOMITANT MEDICAL PRODUCTS: MOTOR: SERIAL (B)(4), MANUFACTURE DATE: 20OCT2015; FLOW PROBE: SERIAL (B)(4), MANUFACTURE DATE: 28NOV2011. THE PRIMARY CONSOLE IS NOT A SINGLE USE DEVICE. APPROXIMATE AGE OF THE DEVICE IS 1 YEAR, 7 MONTHS (CALCULATED FROM THE MANUFACTURE DATE OF THE PRIMARY CONSOLE). THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT HAS NOT YET BEEN RECEIVED. THE EVENT OCCURRED AT (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED ON AN EXTRACORPOREAL CIRCULATORY SUPPORT DEVICE ON (B)(6) 2017 FOR LEFT VENTRICULAR SUPPORT. IT WAS REPORTED THAT ON (B)(6) 2017, THE PRIMARY CONSOLE WITH ASSOCIATED MOTOR AND FLOW PROBE ALARMED "PUMP NOT INSERTED", AND THE DISPLAYED PUMP SPEED READ 0 RPM WHILE IN USE ON THE PATIENT. REPORTEDLY, THE ALARM OCCURRED EVEN THOUGH THE PUMP WAS CONFIRMED TO BE INSERTED CORRECTLY INTO THE MOTOR. IT WAS REPORTED THAT DURING THE 2 ALARM EPISODES, THE FLOW WAS STOPPED FOR A MAXIMUM OF 10 TO 20 SECONDS EACH TIME. IN ADDITION, IT TOOK APPROXIMATELY 10 SECONDS TO CHANGE TO BACKUP EQUIPMENT. THE PATIENT WAS REPORTEDLY NOT HARMED DUE TO THE EVENT AND CONTINUES ON LVAD SUPPORT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695222 THORATEC CENTRIMAG PRIMARY CONSOLE CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention