BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THORATEC CENTRIMAG PRIMARY CONSOLE

    MDR report key: 6973717 · Received October 24, 2017

    Report

    Report Number
    2916596-2017-02433
    Event Type
    Injury
    Date Received
    October 24, 2017
    Date of Event
    May 14, 2017
    Report Date
    October 24, 2017
    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

    THE PATIENT¿S WEIGHT WAS NOT PROVIDED. THE REFERENCED 1ST PRIMARY CONSOLE, MOTOR, AND FLOW PROBE WERE REPORTED UNDER MEDWATCH MFR REPORT # 2916596-2017-01150. UNIQUE IDENTIFIER (UDI) # (DEVICE IDENTIFIER): DEVICE WAS MANUFACTURED PRIOR TO THE UDI LABELING IMPLEMENTATION. THE PRIMARY CONSOLE IS NOT A SINGLE USE DEVICE. APPROXIMATE AGE OF THE DEVICE IS 3 YEARS, 3 MONTHS (CALCULATED FROM THE MANUFACTURE DATE OF THE PRIMARY CONSOLE). THE EVENT OCCURRED AT (B)(6). THE REPORT OF NO FLOW INDICATION WAS ONLY SEEN AND CONFIRMED IN THE LOG FILE OF THE BACKUP PRIMARY CONSOLE. WHILE THE INVOLVED MOTOR WAS STILL OPERATED BY THE FIRST PRIMARY CONSOLE, THE LOG FILE ENTRIES SHOWED THAT FLOW WAS DISPLAYED AS INTENDED. HOWEVER, AFTER SWITCHING THE INVOLVED MOTOR TO THE BACKUP PRIMARY CONSOLE, FLOW VALUES WERE ONLY LOGGED SPORADICALLY, BUT NEVERTHELESS SHOWED THAT FLOW WAS PRESENT. THE BACKUP PRIMARY CONSOLE ALERTED ¿FLOW SIGNAL INTERRUPTED: F2¿ MULTIPLE TIMES. ACCORDING TO THE LOG FILE ENTRIES, THE RETURNED MOTOR ALWAYS OPERATED AS INTENDED AND, WHEN TWO PRESSURE SENSORS WERE CONNECTED TO THE BACKUP PRIMARY CONSOLE, PRESSURE VALUES WERE ALWAYS DISPLAYED CORRECTLY. THE BEHAVIOR SEEN IN THE LOG FILE CONFIRMED THE REPORTED EVENT. THE SUSPECT NO FLOW ISSUE COULD NOT BE REPRODUCED DURING THE MANUFACTURER¿S INVESTIGATION. BOTH PRIMARY CONSOLES WERE EACH TESTED TOGETHER WITH THE RETURNED FLOW PROBE AND MOTOR AT THE SAME WORKING POINTS AS THEY WERE SEEN IN THE LOG FILE FOR TWO DAYS AND NO PROBLEM OR FAULT OCCURRED. THE RETURNED DEVICES OPERATED AS INTENDED THROUGHOUT THE INVESTIGATION AND THE ROOT CAUSE OF THE REPORTED NO FLOW ISSUE COULD NOT BE CONCLUSIVELY DETERMINED. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED ON BIVENTRICULAR EXTRACORPOREAL CIRCULATORY SUPPORT ON (B)(6) 2017. IT WAS REPORTED THAT ON (B)(6) 2017, THE SYSTEM INDICATED THAT THERE WAS NO FLOW, ALTHOUGH THE PUMP ROTOR WAS ROTATING. IT WAS REPORTED THAT THE PATIENT HAD FLOW AND PRESSURE ON THE LEFT VENTRICULAR DEVICE THROUGHOUT THE EVENT, EVEN THOUGH THE PRIMARY CONSOLE DISPLAYED NO FLOW. REPORTEDLY, THE PATIENT WAS NOT INJURED DUE TO THE EVENT. THE FLOW PROBE, MOTOR, AND PRIMARY CONSOLE WERE EXCHANGED FOR BACKUP UNITS. THE PATIENT REMAINED ON BIVENTRICULAR SUPPORT AWAITING TRANSPLANT. ON 27SEP2017 DURING THE INVESTIGATION OF THE RETURNED EQUIPMENT, A SECOND PRIMARY CONSOLE WAS ALSO RETURNED AND WAS FOUND TO BE DIRECTLY INVOLVED IN THE EVENT. THE SECOND PRIMARY CONSOLE WAS REPORTEDLY USED AS A BACKUP UNIT WHEN THE EVENT OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    753017 THORATEC CENTRIMAG PRIMARY CONSOLE CENTRIMAG PRIMARY CONSOLE DWA THORATEC SWITZERLAND GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR Hospitalization| R