BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 2983470 · Received February 28, 2013

    Report

    Report Number
    1722028-2013-00972
    Date Received
    February 28, 2013
    Date of Event
    November 13, 2012
    Report Date
    January 31, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELATED TO THE ASSEMBLY OF THE LUER. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. ROOT CAUSE: THIS DISPOSABLE SET WAS UNAVAILABLE FOR SPECIFIC ROOT CAUSE ANALYSIS. BASED ON THE DESCRIPTION OF THE INCIDENT FROM THE CUSTOMER, THIS WAS LIKELY DUE TO AN INCOMPLETE SEATING OF THE TWO LUER HALVES DURING MANUFACTURING.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IN A CONVERSATION WITH THE CUSTOMER, IT WAS DETERMINED THAT NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT. THE CUSTOMER STATED THAT THEY SET-UP ANOTHER MACHINE AND COLLECTED IN ONE DAY, EVERYTHING WAS FINE AFTER THAT. PER THE CUSTOMER, THERE WERE NO SIGNS OF CONTAMINATION. THE CUSTOMER WAS NOT ABLE TO PROVIDE THE PATIENT'S WEIGHT. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    THE CUSTOMER WAS UNABLE TO PROVIDE THE PATIENT'S WEIGHT.

    Description of Event or Problem · 1

    TERUMO BCT'S QUARTERLY MAUDE DATABASE SEARCH REVEALED A CUSTOMER'S REPORT WITH THE FOLLOWING EVENT DESCRIPTION (REPORT NUMBER (B)(6)):'THE DEVICE WAS SET-UP FOR A STEM CELL COLLECTION AND ONCE THE PROCEDURE STARTED A SMALL AMOUNT OF FLUID WAS NOTED TO BE LEAKING FROM THE COLLECTION BAG TUBING. UPON ASSESSMENT IT WAS NOTED THAT THE LEAKING WAS COMING FROM THE CONNECTION BELOW THE ACDA FILTER. THE CONNECTION WAS LOOSE AND NOT PROPERLY SEALED. 'THE REPORT STATED THAT THERE WAS PATIENT INJURY AND THE PATIENT REQUIRED MEDICAL INTERVENTION. THE EXTENT OF THE INJURY AND MEDICAL INTERVENTION IS NOT KNOWN AT THIS TIME. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. IT IS ALSO NOT KNOWN AT THIS TIME BY WHICH CUSTOMER THIS REPORT WAS SUBMITTED. THE REPORT STATED THAT THE DISPOSABLE SET WAS AVAILABLE FOR EVALUATION, AND THAT THE REPORT WAS SENT TO THE MANUFACTURER, HOWEVER, TERUMO BCT HAS NOT RECEIVED THE REPORT OR THE DEVICE TO DATE. THIS REPORT IS BEING FILED IN RESPONSE TO THE CUSTOMER FILING A SAE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86476 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL COLLECT SET, CLOSED GKT TERUMO BCT 08U15206

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR