BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 2951051 · Received February 8, 2013

    Report

    Report Number
    1722028-2013-00048
    Date Received
    February 8, 2013
    Date of Event
    December 14, 2012
    Report Date
    January 10, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. THE SYMPTOMS AND SEVERITY OF THE PATIENT REACTION WERE INCONSISTENT WITH REACTIONS TO CITRATE AND ETHYLENE OXIDE. THERE HAVE ALSO BEEN NO OTHER REPORTS OF SIMILAR PATIENT REACTIONS ON THIS LOT OF DISPOSABLES, OTHER THAN THE ONES REPORTED BY THIS CUSTOMER SITE. THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. THE CUSTOMER WAS USING CALCIUM GLUCONATE DURING THE PROCEDURE. THIS SOLUTION CONSISTED OF TWO BLISTERS THAT WERE DILUTED WITH 250CC OF SALINE AND WAS ADMINISTERED DIRECTLY THROUGH THE RETURN LINE. THIS IS PER THE CUSTOMER'S NORMAL PROCEDURE. AFTER THE PROCEDURE, IT WAS FOUND THAT THE CALCIUM GLUCONATE BLISTERS THAT WERE BEING USED DURING THIS PROCEDURE HAD BEEN RECALLED BY THE REGULATORY BODY IN ARGENTINA DUE TO MICROBIAL CONTAMINATION. ROOT CAUSE: OPERATOR ERROR OF USING RECALLED CALCIUM GLUCONATE. THE CALCIUM GLUCONATE THAT WAS USED DURING THE PROCEDURE HAD MICROBIAL CONTAMINATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEIR PATIENT HAD TREMORS, FEVER, TACHYPNEA AND TACHYCARDIA DURING THE PROCEDURE. THE PATIENT REQUIRED MEDICAL INTERVENTION IN THE FORM OF STEROIDS. ALL THE BLOOD CULTURE AND PRODUCTS CULTURE TAKEN WERE NEGATIVE. THE DISPOSABLE SET IS NOT AVAILABLE FOR EVALUATION BECAUSE THE CUSTOMER DISCARDED IT. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54582 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET, CLOSED GKT TERUMO BCT 02U15275

    Patients

    Seq Age Sex Outcome Treatment
    1 00047 YR Other