BEUDAMED
    FDA Adverse Event Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 3075612 · Received April 24, 2013

    Report

    Report Number
    1722028-2013-01149
    Date Received
    April 24, 2013
    Date of Event
    April 21, 2012
    Report Date
    March 25, 2013
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    K893962
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    GONZALO ONORO, MD,ET AL. LEUKO REDUCTION IN PATIENTS WITH SEVERE PERTUSSIS WITH HYPERLEUKOCYTOSIS. 'THE PEDIATRIC INFECTIOUS DISEASE JOURNAL'. 2012;31(8): 873-876. INVESTIGATION: TERUMO BCT HAS RECEIVED NO COMPLAINT OF POSSIBLE FAILURE OF THE APHERESIS SYSTEM DURING THIS PROCEDURE, OR COMMUNICATION OF ANY KIND FROM THE STAFF OF THE HOSPITAL WHERE THIS PROCEDURE WAS DONE. THE INFORMATION PRESENTED IN THE REFERENCE HAS BEEN CAREFULLY REVIEWED AND DISCUSSED WITH AN EXTERNAL MEDICAL CONSULTANT. THE DISCUSSION IN THE REFERENCE IMPLICATES ANTICOAGULATION AS A CONTRIBUTORY CAUSE OF THE DEATH OF THIS PATIENT. THE ANTICOAGULANT IS IDENTIFIED AS ACID CITRATE DEXTROSE (ACD), BUT THERE IS NO DESCRIPTION OF THE TOTAL AMOUNT DELIVERED DURING THE PROCEDURE. ACD USED IN APHERESIS PROVIDES ANTICOAGULATION OF THE BLOOD WHILE IT IS IN THE EXTRACORPOREAL CIRCUIT AND DOES NOT INDUCE SYSTEMIC ANTICOAGULATION AS DOES HEPARIN. INFUSION OF EXCESSIVE AMOUNTS OF ACD RESULTS IN SYMPTOMS OF HYPOCALCEMIA, WHICH WHEN EXTREME INCLUDE TETANY AND CARDIAC INSUFFICIENCY. WE ARE AWARE OF NO OTHER REPORTS IN THE LITERATURE IMPLICATING ACD INFUSION WITH SYSTEMIC BLEEDING. THE REPORT INDICATES A 29% REDUCTION ON WBC POST APHERESIS AND A 72% REDUCTION IN PLATELET COUNT. THIS OUTCOME IS UNEXPECTED IN A WBC DEPLETION PROCEDURE BUT IS POSSIBLE IF THE INTERFACE POSITION IS HIGH, THAT IS, PLATELETS INSTEAD OF WBCS ARE PREFERENTIALLY REMOVED. AN ALTERNATIVE POSSIBILITY IS THAT THE OBSERVED DECREASE IN PLATELETS IS ASSOCIATED WITH THE DISSEMINATED INTRAVASCULAR COAGULATION (DIC) THAT IS SOMETIMES ASSOCIATED WITH ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) THE AUTHORS DESCRIBE. THE POST PROCEDURE PLATELET COUNT, INDEPENDENT OF THECAUSE, IS STILL HIGH ENOUGH TO PREVENT BLEEDING DUE TO THROMBOCYTOPENIA. THE INFANT UNDERGOING APHERESIS FOR THE REDUCTION IN CIRCULATING LEUKOCYTES WAS ACUTELY ILL WITH ACIDOSIS, RESPIRATORY FAILURE, REFRACTORY CARDIOGENIC SHOCK, AND WAS AT A HIGH RISK OF MORTALITY. TERUMO BCT HYPOTHESIZES THAT THE PULMONARY AND CNS BLEEDING WERE DUE TO A COAGULOPATHY RELATED TO THE ARDS, POTENTIALLY DIC, AND NOT THE USE OF ACD-A AND THE REDUCTION IN PLATELET COUNT DURING THE PROCEDURE. INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN AND INVESTIGATION. UPON FOLLOWUP WITH THE CUSTOMER, THE STAFF PHYSICIAN INDICATED THAT THE PATIENT'S DEATH WAS DUE TO THE PATIENT'S DISEASE STATE. ROOT CAUSE: PER THE RESEARCH PERFORMED AND THE PATIENT'S PHYSICIAN, THIS INCIDENT WAS THE RESULT OF THE PATIENT'S DISEASE STATE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION EVALUATION AND CORRECTIVE ACTIONS ARE IN-PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED.

    Description of Event or Problem · 1

    A PATIENT DEATH WAS DOCUMENTED IN AN ARTICLE IN 'THE PEDIATRIC INFECTIOUS DISEASE JOURNAL',VOLUME 31, NUMBER 8, AUGUST 2012. THE TITLE OF THE ARTICLE IS LEUKOREDUCTION IN PATIENTS WITH SEVERE PERTUSSIS WITH HYPERLEUKOCYTOSIS. THE ARTICLE DESCRIBES ALEUKO REDUCTION PROCEDURE THAT WAS PERFORMED IN THE CONTEXT OF SEVERE PERTUSSIS AND HYPERLEUKOCYTOSIS. PRIOR TO THE PROCEDURE, THE PATIENT'S CLOTTING PROFILE AND LIVER FUNCTION TEST RESULTS WERE NORMAL. AFTER THE PROCEDURE, THE PATIENT DEVELOPED SEVERE COAGULOPATHY WITH RESPIRATORY BLEEDING AND BILATERAL INTRAVENTRICULAR HEMORRHAGE IDENTIFIED BY CEREBRAL ULTRASOUND. EXITUS WAS WITHIN HOURS OF THE PROCEDURE AND WITHIN 24 HOURS OF HOSPITAL ADMISSION, PER THE ARTICLE. ACID CITRATE DEXTROSE WAS USED AS THE ANTICOAGULANT DURING THE PROCEDURE. VOLUME USED WAS NOT SPECIFIED. THE DATE OF THE PROCEDURE IS NOT KNOWN AT THIS TIME. THE DATE OF THE ARTICLE HAS BEEN PROVIDED. PATIENT IDENTIFIER AND WEIGHT ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN FOR EVALUATION. THIS REPORT IS BEING FILED DUE TO A PATIENT DEATH. PATIENT DEATH IS BELIEVED TO BE DUE TO PATIENT DISEASE-STATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    176990 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00002 MO