BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRA OPTIA IDL SET

    MDR report key: 7333557 · Received March 13, 2018

    Report

    Report Number
    7333557
    Event Type
    Malfunction
    Date Received
    March 13, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 9, 2018
    Manufacturer
    TERUMO BCT, INC.
    Product Code
    LKN
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING ELEMENTS HAVE BLANK DATA.

    Description of Event or Problem · 1

    TERUMO BCT CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC)/IDL KIT HAD A DEFECT IN THE INLET MANIFOLD, THE WELDING CAME UNDONE FOR UNKNOWN REASON. THE PATIENT DID NOT RECEIVE THEIR BLOOD BACK DUE TO THE KIT MALFUNCTION ISSUE. PATIENT WAS IMMEDIATELY DISCONNECTED AND THE ATTENDING PHYSICIAN WAS NOTIFIED OF THE EVENT. MANUFACTURER RESPONSE FOR CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) KIT, TERUMO BCT CMNC (IDL) KIT (PER SITE REPORTER): MANUFACTURER HAS NOT RESPONDED WITH THEIR FINDINGS AT THIS TIME.

    Description of Event or Problem · 1

    TERUMO BCT CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC)/IDL KIT HAD A DEFECT IN THE INLET MANIFOLD, THE WELDING CAME UNDONE FOR UNKNOWN REASON. THE PATIENT DID NOT RECEIVE THEIR BLOOD BACK DUE TO THE KIT MALFUNCTION ISSUE. PATIENT WAS IMMEDIATELY DISCONNECTED AND THE ATTENDING PHYSICIAN WAS NOTIFIED OF THE EVENT. MANUFACTURER RESPONSE FOR CONTINUOUS MONONUCLEAR CELL COLLECTION (CMNC) KIT, TERUMO BCT CMNC (IDL) KIT (PER SITE REPORTER). MANUFACTURER HAS NOT RESPONDED WITH THEIR FINDINGS AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176214 SPECTRA OPTIA IDL SET SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC LKN TERUMO BCT, INC. 1712123230

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO.