BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG MOTOR, OUS

    MDR report key: 7993230 · Received October 22, 2018

    Report

    Report Number
    2916596-2018-04441
    Event Type
    Injury
    Date Received
    October 22, 2018
    Date of Event
    October 3, 2018
    Report Date
    January 12, 2021
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    KFM
    Removal / Correction Number
    FA-Q318-MCS-1
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H6: METHOD CODE WAS INADVERTENTLY NOT INCLUDED IN THE PREVIOUS REPORT. CORRECTED MANUFACTURER'S INVESTIGATION CONCLUSIONS: DURING THE INVESTIGATIONS, THE REPORTED FAULTS WERE SEEN IN THE CONSOLE¿S LOG-FILE. THE COMPLAINT WAS THEREFORE CONFIRMED. HOWEVER, THE FAULT WAS NOT REPRODUCED DURING THE INVESTIGATIONS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE EXPERIENCE OF EARLIER COMPLAINTS, A POSSIBLE ROOT CAUSE OF THE EVENT WAS AN INTERMITTENT CABLE BREAK INSIDE THE MOTOR¿S CABLE, BUT A FAULT INSIDE THE CONSOLE COULD ALSO NOT COMPLETELY BE EXCLUDED, THEREFORE, THE CONSOLE¿S MOTOR CONTROLLER PCB WITH CABLE WAS ALSO SUSPECT. THE FOLLOWING PREVENTIVE ACTIONS WERE THEREFORE PERFORMED: - THE SUSPECT MOTOR SN (B)(6) WAS CLEARLY MARKED WITH RED STICKERS AND SCRAPPED. IT WILL BE STORED FOR ONE YEAR IN QUARANTINE AREA. THE RESPONSIBLE ABBOTT CUSTOMER SERVICE IN ITALY SHALL SEND A NEW MOTOR AS REPLACEMENT FREE OF CHARGE FOR THE CUSTOMER. - THE SUSPECT CONSOLE¿S MOTOR CONTROLLER PCB WITH CABLE WAS REPLACED WITH A NEW ONE. THE REPAIRED CONSOLE WAS FINALLY SUBJECTED TO THE REPAIR AND MAINTENANCE PROCEDURE. THE UNIT PASSED ALL TESTS AND WAS SENT BACK TO THE DISTRIBUTION CENTER, FROM WHERE IT WILL BE FORWARDED TO THE CUSTOMER. THE FOLLOWING EVALUATION WAS PERFORMED BY THORATEC SWITZERLAND GMBH. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE RETURNED 2ND GENERATION CONSOLE AND CENTRIMAG MOTOR REVEALED THAT THE RETURNED DEVICES HAD PASSED ALL INSPECTIONS AND TESTS, BEFORE THEY WERE SHIPPED TO THE DISTRIBUTION CENTER. THE MOTOR INITIALLY SHIPPED ON 01-JUN-2018. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSIONS: DURING THE INVESTIGATION, THE REPORTED FAULTS WERE SEEN IN THE CONSOLE¿S LOG-FILE. THE COMPLAINT WAS THEREFORE CONFIRMED. HOWEVER, THE FAULT WAS NOT REPRODUCED DURING THE INVESTIGATIONS. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE EXPERIENCE OF EARLIER COMPLAINTS, A POSSIBLE ROOT CAUSE OF THE EVENT WAS AN INTERMITTENT CABLE BREAK INSIDE THE MOTOR¿S CABLE, BUT A FAULT INSIDE THE CONSOLE COULD ALSO NOT COMPLETELY BE EXCLUDED, THEREFORE, THE CONSOLE¿S MOTOR CONTROLLER PCB WITH CABLE WAS ALSO SUSPECT. THE REPAIRED CONSOLE WAS FINALLY SUBJECTED TO THE REPAIR AND MAINTENANCE PROCEDURE. THE UNIT PASSED ALL TESTS AND WAS SENT BACK TO THE DISTRIBUTION CENTER, FROM WHERE IT WILL BE FORWARDED TO THE CUSTOMER. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THIS MEDWATCH IS REPORTING THE MOTOR. THE PRIMARY CONSOLE IS REPORTED UNDER MEDWATCH MFR REPORT # 2916596-2018-04442. THE DEVICE IS EXPECTED TO BE RETURNED FOR ANALYSIS. IT HAS NOT YET BEEN RECEIVED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) PROCEDURE, THE PRIMARY CONSOLE DISPLAYED A MOTOR FAILURE. IMMEDIATELY AFTERWARD, THERE WAS A PUMP STOPPAGE AND A LOW FLOW ALARM. THE PRIMARY CONSOLE AND THE MOTOR WERE EXCHANGED, AND THE ECMO STARTED TO RUN AGAIN. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EQUIPMENT WAS STORED CLOSE TO THE BED ON ITS CART. THE MOTOR WAS CONNECTED TO THE MOTOR BRACKET AND TO THE CART. THE MOTOR WAS AT ROOM TEMPERATURE, AND NOTHING RELEVANT WAS CLOSE TO THE MOTOR. DURING THE EVENT, THE RPM AND FLOW WERE NOT ADJUSTED VERY HIGH. REPORTEDLY, THE EQUIPMENT WAS HANDLED 95% OF THE TIME BY EXPERIENCED HOSPITAL STAFF. AT NIGHT, IT IS POSSIBLE THAT NURSES WITHOUT A CONSIDERABLE AMOUNT OF EXPERIENCE ARE CHECKING THE PRIMARY CONSOLE. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    829817 CENTRIMAG MOTOR, OUS PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE KFM THORATEC SWITZERLAND GMBH 201-10002 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention