BEUDAMED
    FDA Adverse Event Summary report: N

    SPECTRA OPTIA

    MDR report key: 2861654 · Received December 7, 2012

    Report

    Report Number
    1722028-2012-00901
    Date Received
    December 7, 2012
    Date of Event
    October 20, 2012
    Report Date
    November 9, 2012
    Manufacturer
    TERUMO BCT
    Product Code
    LKN
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. ROOT CAUSE: BASED ON THE EVIDENCE SEEN IN THE EVALUATION OF THE RETURNED SET, THE ROOT CAUSE FOR THE LEAK IN THE CENTRIFUGE IS LIKELY RELATED TO A MISLOAD OF THE LOWER BEARING.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION: THE SET WAS RETURNED FOR EVALUATION. THE SET WAS VISUALLY INSPECTED. A LACERATION WAS NOTED IN THE LOWER HEX SLEEVE. THERE WAS NOT A WITNESS MARK ON THE LOWER BEARING. THERE WAS A SLIGHT TWIST OF THE CENTRIFUGE COLLAR LINE BELOW THE HEX, AND THE EARS WERE PARTIALLY DAMAGED. THESE FINDINGS ARE LIKELY RELATED TO A MISLOAD OF THE LOWER BEARING. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT DURING THE PROCEDURE, THE KIT BROKE AT THE CENTRIFUGE LEVEL. THERE WAS AN ALARM "TOO HIGH PRESSURE IN THE CENTRIFUGE CHANNEL." IT WAS NOT POSSIBLE TO PERFORM THE RETURN TO THE PATIENT. THE PATIENT WAS DISCONNECTED. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. 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
    1 SPECTRA OPTIA SPECTRA OPTIA EXCHANGE SET LKN TERUMO BCT 08U3201

    Patients

    Seq Age Sex Outcome Treatment
    1