BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 3092649 · Received May 3, 2013

    Report

    Report Number
    1722028-2013-01186
    Date Received
    May 3, 2013
    Date of Event
    February 4, 2013
    Report Date
    April 15, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    PMA / PMN Number
    BK870022
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED

    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. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. THE MISSING INJECTION PORT WAS MOST LIKELY CAUSED BY, BUT NOT LIMITED TO, THE RESULT OF A VENDOR COMPONENT DEFECT.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING SET-UP OF THE DISPOSABLE SET, IT WAS OBSERVED THAT A PLUG WAS MISSING AT THE INSERTION POINT (PORT) OF THE COLLECT BAG. DUE TO THIS, THE PATIENT WAS NOT CONNECTED AND A NEW KIT WAS LOADED. THERE WAS NOT A TRANSFUSION PATIENT INVOLVED AT THE TIME OF THE DISPOSABLE KIT SET-UP, THEREFORE, NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT. THE DISPOSABLE SET IS UNAVAILABLE FOR RETURN BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT WITH THEIR LOCAL AUTHORITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194258 SPECTRA OPTIA SPECTRA OPTIA COLLECT SET LKN TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1