BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 4101589 · Received September 19, 2014

    Report

    Report Number
    1722028-2014-00379
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 22, 2014
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDR'S, PER FDA REQUEST, TO IDENTIFY RECORDS IN WHICH A SERIOUS INJURY OR MEDICAL INTERVENTION OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED AS A SERIOUS INJURY OF THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION PER FDA REQUEST.

    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. A REVIEW OF THE LOT FOR SIMILAR REPORTS WAS CARRIED OUT, NONE HAVE BEEN REPORTED. PER THE CUSTOMER, THE PATIENT DID NOT HAVE ANY PREVIOUSLY KNOWN ALLERGIES. THIS WAS THE PATIENT¿S FIRST COLLECTION PROCEDURE. NO FLUIDS WERE USED OTHER THAN ACDA DURING THE PROCEDURE. FOLLOWING THE ADMINISTERING OF THE DRUGS AND THE PERIOD OF REST FOR THE PATIENT, THE PROCEDURE WAS RESTARTED BUT ULTIMATELY ENDED EARLY DUE TO A CLOT IN THE INLET LINE. THE APHERESIS PRODUCT CONTAINED 3.4X10^6 CD34+VE CELLS/ KG BW. ON (B)(6), THE INFUSION OF THE CRYOPRESERVED AUTOLOGOUS STEM CELLS WAS PERFORMED WITHOUT ANY ALLERGIC SYMPTOMS. ACCORDING TO THE THERAPEUTIC APHERESIS: A PHYSICIAN¿S HANDBOOK, SECOND EDITION, ONE OF THE MOST COMMON COMPLICATIONS SEEN DURING THERAPEUTIC PROCEDURES IS URTICARIA, ESPECIALLY DURING THE FIRST PROCEDURE. ROOT CAUSE: ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, THE SYMPTOMS OF THE PATIENT¿S ALLERGIC REACTION AND THE EFFECTIVENESS OF THE MEDICATION PRESCRIBED MAKE THE ROOT CAUSE LIKELY TO BE HYPOCALCAEMIA DUE TO THE ACDA.

    Additional Manufacturer Narrative · 1

    PER THE COBE SPECTRA APHERESIS SYSTEM ESSENTIALS GUIDE, IT PROVIDES THE FOLLOWING CAUTIONS AND SUGGESTIONS TO THE OPERATOR WITH RESPECT TO A PATIENT REACTION: BE AWARE OF POSSIBLE PATIENT REACTIONS DURING APHERESIS PROCEDURES. PREVIOUSLY REPORTED REACTIONS TO APHERESIS PROCEDURES INCLUDE URTICARIA, ALLERGIC REACTIONS, AMONG OTHERS. BE PREPARED TO TAKE APPROPRIATE ACTION SHOULD ANY OF THESE SYMPTOMS APPEAR. ROOT CAUSE: THE ROOT CAUSE FOR THE CLOT IN THE INLET LINE WAS POSSIBLY CAUSED BY, BUT NOT LIMITED TO, TOO LOW OF AN AC RATIO AND EXTENDED MACHINE PAUSE TIME.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PATIENT HAD AN ALLERGIC REACTION DURING A STEM CELL COLLECTION PROCEDURE. APPROXIMATELY 90 MINUTES INTO THE PROCEDURE, THE PATIENT DEVELOPED MASSIVE SYMMETRIC URTICARIA ON BOTH HANDS, WRIST JOINT, ARM, EAR, AND GROIN. PER PHYSICIAN'S ORDER, INTRAVENOUS 2 AMPULES FENISTIL, 1 RANITIDIN, AND 100 MG PREDNISOLON WERE ADMINISTERED TO THE PATIENT VIA IV. THE CUSTOMER STATED THAT THE PATIENT HAD OBVIOUS IMPROVEMENTS AFTER THE MEDICATION. THE PATIENT STAYED FOR OBSERVATION IN THE CLINIC, THEN WAS FULLY RECOVERED APPROXIMATELY AN HOUR AND A HALF LATER. DUE TO EU PERSONAL DATA PROTECTION LAWS, THE PATIENT INFORMATION IS NOT AVAILABLE FROM THE CUSTOMER. THE DISPOSABLE KIT IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THIS REPORT IS BEING FILED DUE TO MEDICAL INTERVENTION IN THE FORM OF INTRAVENOUS 2 AMPULES FENISTIL, 1 RANITIDIN, AND 100 MG PREDNISOLON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584344 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET, CLOSED GKT TERUMO BCT 08V15251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention