BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 19533261 · Received June 13, 2024

    Report

    Report Number
    2916596-2024-03260
    Event Type
    Death
    Date Received
    June 13, 2024
    Date of Event
    March 7, 2024
    Report Date
    September 12, 2024
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    QNR
    UDI-DI
    07640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: THE INITIAL REPORT WAS INCORRECTLY SUBMITTED WITH A CFN-BASED MANUFACTURER REPORT (MFR) NUMBER: 2916596-2024-03260. THE MFR NUMBER SHOULD HAVE BEEN FEI-BASED WITH THE 10 DIGIT FEI BEING 3003306248. MANUFACTURER'S INVESTIGATION CONCLUSION: A DIRECT CORRELATION BETWEEN THE CENTRIMAG BLOOD PUMP AND THE REPORTED EVENTS AND SUBSEQUENT PATIENT OUTCOME COULD NOT CONCLUSIVELY BE DETERMINED THROUGH THIS EVALUATION. THE SERIAL NUMBER OR OTHER IDENTIFYING INFORMATION OF THE PRODUCT WAS NOT REPORTED AND WAS NOT ABLE TO BE DETERMINED DURING THE INVESTIGATION. THE CENTRIMAG BLOOD PUMP INSTRUCTIONS FOR USE (IFU) (REV. C) LISTS DEATH AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE CENTRIMAG CIRCULATORY SUPPORT SYSTEM. THIS IFU ALSO PROVIDES THE FOLLOWING WARNINGS AND CAUTIONS: IFU WARNING #10: FREQUENT PATIENT AND DEVICE MONITORING IS RECOMMENDED. IFU CAUTION #2: THIS DEVICE SHOULD ONLY BE USED BY PERSONS THOROUGHLY TRAINED IN EXTRACORPOREAL CIRCULATION PROCEDURES. IFU CAUTION #15: ALWAYS HAVE A BACKUP CENTRIMAG PUMP, CONSOLE, MOTOR, AND ACCESSORIES AVAILABLE FOR USE. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    SECTION D4: DEVICE SERIAL NUMBER AND LOT NUMBER WERE NOT PROVIDED, AND EXPIRATION DATE AND MANUFACTURE DATE (H4) CANNOT BE DETERMINED. THE PRIMARY UDI NUMBER IN D4 IS REFLECTIVE OF ALL AVAILABLE INFORMATION. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A CENTRIMAG CONSOLE SHOWED ERROR CODE S3 MULTIPLE TIMES AND WAS SENT IN FOR SERVICE. IT WAS COMMUNICATED THAT THE ONLY TROUBLESHOOTING THAT WAS PERFORMED WAS TO ENSURE ALL CABLES AND CONNECTIONS WERE APPROPRIATELY AND SECURELY CONNECTED. THE ¿S3¿ ALERT, PER THE CENTRIMAG ALARM REFERENCE SECTION OF THE INSTRUCTIONS FOR USE (IFU) DID NOT OFFER ANYTHING IN THE WAY OF WHAT COULD CAUSE SUCH AN ALERT, SO TROUBLESHOOTING WAS MINIMAL WHEN THERE WAS NO NOTED AREA OF CONCERN TO DIRECT STAFF TO MORE APPROPRIATE TROUBLESHOOTING. THE ALARM WAS ABLE TO BE CLEARED, BUT RETURNED, AND AS RECOMMENDED ON THE CENTRIMAG ALARM REFERENCE CARD, THE CONSOLE WAS URGENTLY EXCHANGED TO A BACKUP CONSOLE UNIT. FOLLOWING THE CONSOLE EXCHANGE, THE ALARM DID NOT OCCUR AGAIN WITH THE SECONDARY CONSOLE. THE DEVICE WAS RETURNED TO ABBOTT VIA THE SITES MEDICAL ENGINEERING TEAM AND HAD SINCE BEEN RETURNED TO THE SITE. ADDITIONALLY, THE REPORTER WAS INFORMED THAT ABBOTT DID NOT PERFORM ANY CORRECTIVE SERVICE ON THE AFFECTED CONSOLE, BUT RATHER, THE CONSOLE WAS RETURNED TO TUFTS MEDICAL CENTER MEDICAL ENGINEERING WITH A RECOMMENDATION THAT THE UNIT BE CLEANED AS THERE WAS AN EXCESS OF DUST ACCUMULATION THAT WAS CAUSING SOME OVERHEATING OF THE CONSOLE UNIT AND THEREBY CAUSING THE ¿S3¿ ALERT. IT WAS ADDITIONALLY COMMUNICATED ON 24MAY2024 THAT THE DEVICE IN QUESTION WAS PHYSICALLY ON A PATIENT PROVIDING VENO-VENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (VV ECMO) SUPPORT AT THE TIME OF THE INCIDENT. NO HARM WAS NOTED WITH REGARDS TO THE PATIENT AT THE TIME OF THE INCIDENT. THE AFFECTED CONSOLE WAS SWITCHED OUT TO A BACKUP CONSOLE UNEVENTFULLY. ULTIMATELY, HOWEVER, THE PATIENT DID PASS AWAY, SEVERAL WEEKS AFTER THIS DEVICE INCIDENT, AND THIS INCIDENT HAD NO PERCEIVED OR ACTUAL CAUSE IN THE PATIENT'S DEATH. IT WAS STATED ON (B)(6) 2024 THAT THE PATIENT WAS STILL ON CENTRIMAG SUPPORT AT DATE AND TIME OF PASSING. THE PATIENT HAD AN ACUTE UPTRENDING OF LACTATE OF UNKNOWN ORIGIN DAY PRIOR TO ARREST. THE PATIENT HAD RETURN OF SPONTANEOUS CIRCULATION TWICE, AND WHEN THE PATIENT ARRESTED FOR THE THIRD TIME, THE FAMILY ELECTED NOT TO PURSUE ADDITIONAL CARDIOPULMONARY RESUSCITATION. THE PATIENT SUBSEQUENTLY PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766801 CENTRIMAG BLOOD PUMP BLOOD PUMP FOR ECMO, LONG-TERM (> 6 HOURS) USE QNR THORATEC SWITZERLAND GMBH 102953 07640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Death