BEUDAMED
    FDA Adverse Event Death Summary report: N

    SPECTRA OPTIA

    MDR report key: 4157319 · Received October 9, 2014

    Report

    Report Number
    1722028-2014-00411
    Event Type
    Death
    Date Received
    October 9, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 17, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK130065
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION IN TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    RETRAINING TO THE MNC PROTOCOL WAS PERFORMED BY A TERUMO BCT CLINICAL SPECIALIST ON (B)(6) OF 2014. ROOT CAUSE: THE CAUSE OF DEATH ABOUT 48 HOURS POST-PROCEDURE WAS STATED BY THE CUSTOMER TO BE ACUTE RENAL FAILURE AND DIC. THE SPECTRA OPTIA MACHINE DID NOT LIKELY CONTRIBUTE TO THE DEATH OF THE PRIMATE. THE INLET PRESSURE TOO LOW ALARMS CAN BE, BUT NOT EXCLUSIVELY, CAUSED BY CLOTTING OR ADEQUATE LINE ACCESS.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: AN INTERNAL INVESTIGATION HAS BEEN INITIATED AT THE CUSTOMER'S SITE. THE CUSTOMER STATED THAT THEY ARE INVESTIGATING IF THE (B)(6) HAD ANY PRE-DISPOSING ISSUES THAT WOULD HAVE CAUSED THE DEATH. THE CUSTOMER REQUESTED FOR RE-TRAINING ON THE SPECTRA OPTIA MACHINE. TERUMO BCT SERVICE REPRESENTATIVE PERFORMED A FULL FUNCTIONAL CHECK, INCLUDING THE LEAK DETECTOR, ON THE SPECTRA OPTIA DEVICE WITH NO DISCREPANCIES FOUND. THE PROBLEM COULD NOT BE DUPLICATED DURING CHECKOUT. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. THERE WERE SEVERAL ALARMS DURING THIS PROCEDURE WHICH ARE NOT UNCOMMON TO OCCUR DURING PROCEDURES ON SMALL PATIENTS WITH A SMALL TOTAL BLOOD VOLUME. AS THE PROCEDURE PROGRESSED THE SYSTEM PREDICTED THAT THE FLUID BALANCE LIMITS WOULD BE EXCEEDED BASED ON THE CURRENTLY ENTERED PATIENT INFORMATION AND RUN VALUES, AND REQUIRED OPERATOR CONFIRMATION IN ORDER TO CONTINUE WITH THE COLLECTION. THE SIGNALS IN THE RUN DATA FILE INDICATE THAT THE SPECTRA OPTIA SYSTEM OPERATED AS INTENDED AND IS SAFE TO USE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PRIMATE EXPIRED 2 DAYS AFTER A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE. THE CUSTOMER STATED THAT DURING THE PROCEDURE ON (B)(6) 2014, THEY HAD SOME ACCESS ISSUES AND SOME CLUMPING IN THE INLET MANIFOLD, THEN A LEAK DETECTED ALARM THAT THEY COULDN'T CLEAR. THEY KEPT THE ANIMAL ANESTHETIZED BY GAS AND HE RECOVERED AFTER THE PROCEDURE, BUT WAS 'OFF'. HE WENT INTO ACUTE RENAL FAILURE AND DISSEMINATED INTRAVASCULAR COAGULATION (DIC) AND EXPIRED ON (B)(6) 2014. THE CUSTOMER IS NOT ALLEGING A DEFICIENCY WITH THE DISPOSABLE SET OR DEVICE. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO A PATIENT ((B)(6)) DEATH, THOUGH AT THIS TIME, THE DEVICE IS NOT SUSPECTED OR ALLEGED TO BE A CONTRIBUTORY FACTOR IN THE DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635707 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00008 YR