BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 6598248 · Received May 30, 2017

    Report

    Report Number
    1722028-2017-00197
    Event Type
    Injury
    Date Received
    May 30, 2017
    Date of Event
    May 5, 2017
    Report Date
    May 30, 2017
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK020041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: BASED ON THE ARTICLE LEUKOCYTE DEPLETION BY THERAPEUTIC LEUKOCYTAPHERESIS IN PATIENTS WITH LEUKEMIA, WBCD PROCEDURES ARE USED TO SYMPTOMATICALLY TREAT PATIENTS WITH HIGH WBC COUNTS THAT ARE THE RESULT OF AN UNDERLYING DISEASES, SUCH AS LEUKEMIA. THE DIAGNOSIS FOR THE PATIENT IN THIS RECORD IS UNKNOWN. HOWEVER, THE ARTICLE SERVES AS A REFERENCE FOR ADVERSE EVENTS THAT CAN OCCUR AND SHOULD BE MONITORED FOR DURING A THERAPEUTIC LEUKOCYTAPHERESIS PROCEDURE. A PREVENTIVE MAINTENANCE (PM) WAS PERFORMED ON THE COBE SPECTRA DEVICE AND NO ISSUES WERE NOTED. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED. CITATION: HÖLIG, K., & MOOG, R. (2012). LEUKOCYTE DEPLETION BY THERAPEUTIC LEUKOCYTAPHERESIS IN PATIENTS WITH LEUKEMIA. TRANSFUSION MEDICINE AND HEMOTHERAPY, 39(4), 241-245. DOI:10.1159/000341805

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: THE CUSTOMER ORIGINALLY CALLED TO INQUIRE IF A WHITE BLOOD CELL DEPLETION (WBCD) PROCEDURE CAN BE PERFORMED WITH A CONCURRENT TREATMENT OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). TERUMO BCT SUPPORT SPECIALIST INFORMED THE CUSTOMER THAT WBCD PROCEDURES DO NOT REPLACE VOLUME BEING REMOVED AS IN THERAPEUTIC PLASMA EXCHANGE (TPE) PROCEDURES. PER PHYSICIAN'S ORDER, THE WBCD PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT THE CONCURRENT TREATMENT OF CRRT AND THE PATIENT IS DOING WELL. ROOT CAUSE: ROOT CAUSE OF THE PATIENT REACTION COULD NOT BE DETERMINED AT THIS TIME, HOWEVER, AS REPORTED BY THE CUSTOMER, THE PATIENT REACTION AND THE SUBSEQUENT MEDICAL INTERVENTION WERE UNRELATED TO THE WBCD PROCEDURE THAT WAS ULTIMATELY SUCCESSFULLY PERFORMED ON THE COBE SPECTRA. AS STATED BY THE CUSTOMER, THE PATIENT'S CONDITION WAS ALREADY UNSTABLE AT THE TIME THE PROCEDURE WAS PERFORMED. ONCE THE PATIENT WAS STABILIZED, THE WBCD PROCEDURE WAS COMPLETED SUCCESSFULLY ON THE COBE SPECTRA. POSSIBLE CAUSES FOR THE PATIENT REACTION INCLUDE BUT ARE NOT LIMITED TO THE PATIENT'S DISEASE STATE, AND/OR THE NATURE OF WBCD PROCEDURES.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: ACCORDING TO THE THERAPEUTIC APHERESIS REFERENCE, LEUKOCYTAPHERESIS (WBCDEPLETION) HAS A 5.7% FREQUENCY FOR ADVERSE EVENTS. THE REFERENCE ALSO LISTS THERAPEUTIC APHERESIS REACTION TYPES OF TACHYCARDIA (0.4%) AND SEIZURE (0.2%). MOST COMPLICATIONS FROM THERAPEUTIC APHERESIS ARE CONSIDERED MINOR AND WELL TOLERATED. THE REFERENCE ALSO STATES THAT EVEN WITH THE MOST CAREFUL PLANNING AND MONITORING, REACTIONS MAY OCCUR DURING THERAPEUTIC APHERESIS. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION. INVESTIGATION: FURTHER CLARIFICATION WAS RECEIVED FROM THE CUSTOMER. THE CUSTOMER STATED THAT THE CODE HAD NOTHING TO DO WITH THE PROCEDURE. THE PATIENT WAS IN UNSTABLE CONDITION AT THE TIME OF THE PROCEDURE AND THE PHYSICIAN FELT IT WAS NECESSARY TO CALL A CODE. INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT APPROXIMATELY 10 MINUTES INTO A WHITE BLOOD CELL DEPLETION(WBCD) PROCEDURE, THE PATIENT'S HEART RATE DECREASED AND BECAME UNRESPONSIVE. PER PHYSICIAN'S ORDER, A CODE WAS CALLED. THE PROCEDURE WAS STOPPED WITHOUT RINSEBACK, THE PATIENT WAS INTUBATED AND WAS GIVEN ANOTHER VASCATH CATHETER. PER THE CUSTOMER, THE PROCEDURE WAS RESTARTED AND THE PATIENT IS DOING WELL. THE PATIENT IS REPORTED IN STABLE CONDITION. PATIENT IDENTIFIER IS NOT AVAILABLE AT THIS TIME. THE WBCD SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    FURTHER CLARIFICATION WAS RECEIVED FROM THE CUSTOMER. THE CUSTOMER STATED THAT APPROXIMATELY 10 MINUTES INTO THE PROCEDURE, A CODE WAS CALLED. THE PATIENT STABILIZED AFTER A FEW HOURS LATER. THE PROCEDURE WAS RESTARTED AND SUCCESSFULLY COMPLETED. THE CUSTOMER DECLINED TO PROVIDE PATIENT IDENTIFIER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379706 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT 07Z15270

    Patients

    Seq Age Sex Outcome Treatment
    1 00075 YR Required Intervention