BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 5564065 · Received April 8, 2016

    Report

    Report Number
    1722028-2016-00208
    Event Type
    Injury
    Date Received
    April 8, 2016
    Date of Event
    November 5, 2015
    Report Date
    April 8, 2016
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: FURTHER EVALUATION OF THIS EVENT HAS DETERMINED THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY BASED ON ADDITIONAL INVESTIGATIONAL INFORMATION. CAUSE OR IN CHARGE, AND CO-AUTHOR OF THE STUDY, CONFIRMED THAT THERE WAS NO MEDICAL INTERVENTION REQUIRED FOR THE PATIENT REACTION. ACCORDING TO THE AABB THERAPEUTIC APHERESIS: A PHYSICIANS HANDBOOK, THE RATE OF ADVERSE EVENTS DURING THERAPEUTIC APHERESIS IS 4-5%.A SPECIFIC DEVICE HISTORY RECORD REVIEW COULD NOT BE PERFORMED DUE TO LACK OF LOT INFORMATION,HOWEVER, ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. ROOT CAUSE: THE DISPOSABLE SET WAS UNAVAILABLE FOR RETURN. THE STUDY ACKNOWLEDGES THAT THE PATIENT REACTION WAS DUE TO CITRATE TOXICITY AND UNDERSTANDS THIS IS A FREQUENT COMPLICATION OF APHERESIS PROCEDURES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PER THE CUSTOMER, NO MEDICAL INTERVENTION WAS REQUIRED FOR THIS EVENT.

    Description of Event or Problem · 1

    AN ARTICLE IN 'TRANSFUSION AND APHERESIS SCIENCE', NOVEMBER 2015, DOCUMENTED A RETROSPECTIVE ANALYSIS OF PERIPHERAL BLOOD STEM CELL (PBSC) COLLECTIONS PERFORMED MARCH 2010 - DECEMBER 2013. OF THE COLLECTIONS THAT WERE ANALYZED, THERE WERE 63 OCCURRENCES OF PATIENTS SUFFERING FROM HYPOCALCEMIA DURING THE PBSC COLLECTIONS ON COBE SPECTRA. THE SYMPTOMS INCLUDED PERIPHERAL PARESTHESIA FOLLOWED BY DIGITAL NUMBNESS. IT IS NOT KNOWN AT THIS TIME IF MEDICAL INTERVENTION WAS REQUIRED FOR THE PATIENT REACTIONS. FORTY OF THE 63 PATIENTS HAD BEEN INJECTED WITH A 5-10ML BOLUS OF 10% CALCIUM GLUCONATE DURING THE PROCEDURE AS PART OF THE STUDY. TWENTY OF THE 63 PATIENTS HAD CONTINUOUS 10% CALCIUM GLUCONATE INFUSED DURING THE PROCEDURE AS PART OF THE STUDY. PATIENT INFORMATION IS NOT AVAILABLE AT THIS TIME. THIS REPORT IS BEING FILED FOR ONE OF THE 63 PATIENTS. EXACT DETAILS OF EACH PATIENT REACTION ARE NOT AVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER. THE TITLE OF THE ARTICLE IS 'PROPHYLACTIC LOW DOSE CONTINUOUS CALCIUM INFUSION DURING PERIPHERAL BLOOD STEM CELL (PBSC) COLLECTIONS TO REDUCE CITRATE RELATED TOXICITY'.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220852 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA AUTOPBSC SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 Other