BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 6060879 · Received October 27, 2016

    Report

    Report Number
    1722028-2016-00576
    Event Type
    Injury
    Date Received
    October 27, 2016
    Date of Event
    October 2, 2016
    Report Date
    October 27, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ADDITIONAL INVESTIGATION: A SERVICE CALL WAS PLACED AND A FULL MACHINE CHECKOUT WAS PERFORMED. ALL TESTS WERE SUCCESSFULLY COMPLETED. THE MACHINE IS FUNCTIONING PER MANUFACTURER'S SPECIFICATION.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION IN DESCRIBE EVENT OR PROBLEM AND ADDITIONAL MFR NARRATIVE. UPDATED ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE PATIENT'S REACTION COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THE ALLEGED CITRATE REACTION INCLUDE BUT ARE NOT LIMITED TO AC MANAGEMENT DURING THE PROCEDURE, PATIENT DISEASE STATE, AND/OR PATIENT SENSITIVITY TO ANTICOAGULANT.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. 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. PER AABB THERAPEUTIC APHERESIS: A PHYSICIAN'S HANDBOOK, THE RATE OF ADVERSE EVENTS DURING THERAPEUTIC APHERESIS IS (B)(4)% WITH THE RISK BEING SLIGHTLY HIGHER DURING A FIRST-TIME PROCEDURE. WITHIN THE STUDY, MOST COMPLICATIONS WERE MINOR AND WELL TOLERATED. PER THE COBE SPECTRA ESSENTIALS GUIDE, THE COBE SPECTRA SYSTEM HAS MANY SAFETY FEATURES. A DONOR AND/ OR PATIENT REACTION CAN OCCUR RAPIDLY, HOWEVER. IT IS IMPERATIVE THAT THE OPERATOR CONTINUOUSLY MONITOR THE COBE SPECTRA SYSTEM AND THE DONOR AND/ OR PATIENT. ROOT CAUSE: BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER, THE CAUSE FOR THE MEDICAL INTERVENTION WAS DUE TO THE PATIENT¿S REACTION TO CITRATE. THE SERVICE CALL CONFIRMED THAT THEREWAS NO DEVICE MALFUNCTION AND THAT THE MACHINE WAS FUNCTIONING AS DESIGNED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A DONOR HAD A CITRATE REACTION AT THE BEGINNING OF A GRANULOCYTE COLLECTION PROCEDURE. THE DONOR COMPLAINED OF FEELING NAUSEATED, TINGLING, AND NUMBNESS AND DEVELOPED MUSCLE STIFFNESS. PER PHYSICIAN'S ORDER, SALINE WAS GIVEN TO THE DONOR VIA IV. DONOR'S OUTCOME IS NOT KNOWN AT THIS TIME. THE CUSTOMER DECLINED TO PROVIDE PATIENT (DONOR) INFORMATION. THE WHITE BLOOD CELL COLLECTION SET IS NOT AVAILABLE FO RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. LOT #, EXPIRATION DATE, AND MANUFACTURE DATE ARE NOT AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT RESPOND TO ATTEMPTS TO OBTAIN INFORMATION FOR THE INVESTIGATION SUCH AS PATIENT INFORMATION, OUTCOME, AND LOT INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710665 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention