BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA

    MDR report key: 3983014 · Received August 6, 2014

    Report

    Report Number
    1722028-2014-00295
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    May 6, 2014
    Report Date
    July 10, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK870022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: . THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER PERTAINING TO THIS EVENT,THEREFORE A DEVICE HISTORY RECORD (DHR) SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA BEFORE RELEASE. THE RUN DATA FILE (RDF) WAS ANALYZED FOR THIS EVENT. ROOT CAUSE: THE ROOT CAUSE WAS UNDETERMINED. THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. REVIEW OF THE RDF ALONG WITH THE IMAGES SHOW THAT THE CAUSE OF THE RED PRODUCT IS LIKELY A COMBINATION OF CLUMPING IN THE COLLECT PORT AND A LIGHTING ISSUE. THE RBC DETECTOR WAS TRIGGERING EARLIER THAN EXPECTED. ALSO, THE IMAGES SHOW THAT THE LIGHTING IS BRIGHTER THAN NORMAL. IF THE AIM SYSTEM DOES NOT SEE A CRISP DELIMITATION OF THE COLLECT PORT IT CALCULATES IT AS BEING LIGHTER THAN IT ACTUALLY IS AND CAUSES THE SYSTEM TO COLLECT A DARKER THAN DESIRED PRODUCT. IF THERE IS A FILM ON THE CAMERA STROBE WINDOW, THE LIGHT IS DIFFUSED AROUND THE COLLECT PORT MAKING THE COLLECT PORT APPEAR LIGHT EVEN WHEN RBCS ARE FLOWING THROUGH THE PORT AND CAN ALSO CAUSE TROUBLE ESTABLISHING THE INTERFACE. THIS NORMALLY OCCURS AFTER THE CAMERA WINDOW IS CLEANED WITH A DISINFECTANT WIPE THAT LEAVES A SOAP FILM ON THE TOP CAMERA STROBE WINDOW. UNFORTUNATELY YOU CANNOT NORMALLY SEE THIS FILM ON THE TOP CAMERA WINDOW IF THE OPERATOR VISUALLY INSPECTS THE BASIN. THE IMAGES WERE REVIEWED FOR THIS PROCEDURE AND THERE WERE SIGNS OF PLATELET CLUMPING IN THE COLLECT PORT. THE INLET:AC RATIO WAS AT 12:1 INITIALLY, AND WAS NOT ADJUSTED THROUGHOUT THE ENTIRETY OF THE PROCEDURE. IT MAY BE PATIENT RELATED. HOWEVER, IN THE FUTURE THE OPERATOR SHOULD FOLLOW THE PROCEDURE RECOMMENDATIONS WHEN CLUMPING IS FOUND. POSSIBLE CAUSES OF BRIGHT LIGHTING ARE A MIS-CALIBRATED LIGHTING SYSTEM, CALIBRATION TO A POOR DIFFUSA AND THEN A NEW DIFFUSER PUT IN (OR THE FILLER CHANGED) WITHOUT RE-MEASURING THE LIGHTING USING STS, BUSTED CAL POT ON THE LIGHTING BOARD DRIVING THE VOLTAGE TOO HIGH.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY RECEIVED A RED CELL CONTAMINATION ALARM DURING A COLLECTION PROCEDURE. THEY WERE UNABLE TO CLEAR THE ALARM RESULTING IN THEM COLLECTING FEWER WHITE CELLS AND FEWER MONONUCLEAR CELLS THAN EXPECTED. DUE TO EU PERSONAL PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Description of Event or Problem · 1

    THE SEX AND WEIGHT OF THE PATIENT WERE OBTAINED FROM THE RUN DATA FILE. NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    461564 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other