BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 8981449 · Received September 10, 2019

    Report

    Report Number
    1722028-2019-00258
    Event Type
    Malfunction
    Date Received
    September 10, 2019
    Date of Event
    August 16, 2019
    Report Date
    September 10, 2019
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    K183081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN AND UPDATED INFORMATION IS PROVIDED IN THE INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIESDURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE.INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED TO PROVIDE INVESTIGATION: DURING FOLLOW-UP WITH THE CUSTOMER, IT WAS REPORTED THAT THEY SAW THE AIR AFTERPRIMING THE RETURN LINE. THEY STARTING USING THE SETS AND CONTINUE TO SEE THE AIR POCKET AND ITDOESN'T MOVE.INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION: THE CUSTOMER PROVIDED 3 PICTURES AND A VIDEO TO TERUMO BCT TO AID IN THE INVESTIGATION. THE PICTURES AND VIDEO CONFIRMED A SMALL AMOUNT OF AIR TRAPPED IN THE AREA OF THE RETURN LINE MANIFOLD AT THE NEEDLE INJECTION SITE. THE AMOUNT OF AIR SEEN WAS 0.1 - 0.2 ML. CORRECTION: INFORMATION WAS PROVIDED TO THE CUSTOMER REGARDING AIR IN THE RETURN LINE MANIFOLD, NO FURTHER RETRAINING WAS REQUIRED. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, THE AIR IN THE RETURN MANIFOLD IS DUE TO INADEQUATE PRIMING OF THE RETURN MANIFOLD DURING SALINE PRIME. AS A RESULT, A SMALL AIR BUBBLE WAS TRAPPED IN THE NEEDLE INJECTION SITE.

    Additional Manufacturer Narrative · 1

    (B)(6): PER THE CUSTOMER, THE AMOUNT OF AIR SEEN WAS APPROXIMATELY 0.1-0.2 MLS. THE CUSTOMER WAS PROVIDED WITH SUPPORT DOCUMENTATION AFTER DISCUSSION WITH TERUMO BCT MEDICAL LIAISON; A LINK TO A MEDSCAPE ARTICLE IS PROVIDED THAT STATES "THE RAPID INGRESS OF LARGE VOLUMES OF AIR 0.30 ML/KG/MIN) INTO THE VENOUS CIRCULATORY SYSTEM CAN OVERWHELM THE AIR-FILTERING CAPACITY OF THE PULMONARY VESSELS, RESULTING IN A MYRIAD OF CELLULAR CHANGES."THUS A SINGLE 0.2 ML OF AIR WOULD NOT POSE A RISK EVEN FOR A VERY SMALL PATIENT. ALSO, TERUMO BCT CUSTOMER SUPPORT PROVIDED A WHITE PAPER ON OUTGASSING "OUTGASSING WITH THE USE OF A BLOOD WARMER IN COBE SPECTRA APHERESIS SYSTEM OR SPECTRA OPTIA APHERESIS SYSTEM THERAPEUTIC APHERESIS PROCEDURES" - GASEOUS BUBBLES THAT ARE INFUSED INTO HUMAN VENOUS BLOODAT RATES =0.10 ML/KG/MIN, THEN PULMONARY DISSIPATION MECHANISMS WILL BE ADEQUATE TO PREVENT EMBOLIZATION OF THE ARTERIAL CIRCUIT. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE PERFORMING VALIDATION TEST ON SPECTRA OPTIA DURING PRIMING FORAN EXCHANGE PROCEDURE THEY OBSERVED AIR IN THE RETURN LINE AT MANIFOLD AND AT NEEDLE INJECTION SITE. PER THE CUSTOMER THEY TRIED TO REMOVE THE AIR BUBBLES BY FLUSHING THE LINE BUT IT DID NOT MOVE. THE CUSTOMER CONTACTED TERUMO BCT FOR TROUBLESHOOTING. THE SUPPORT SPECIALIST INSTRUCTED THE OPERATOR TO DISCUSS THE BUBBLE SIZE WITH THE PHYSICIAN AT SITE AND SUGGESTED TO ASPIRATE THE BUBBLE IF IT DID NOT FLUSH OUT. THERE WAS NO DONOR CONNECTED FOR THIS EVENT, THEREFORE NO DONOR INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE SPECTRA OPTIA EXCHANGE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    780705 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 1905303330

    Patients

    Seq Age Sex Outcome Treatment
    1 Other