BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 5032197 · Received August 26, 2015

    Report

    Report Number
    1722028-2015-00501
    Event Type
    Death
    Date Received
    August 26, 2015
    Date of Event
    July 23, 2015
    Report Date
    July 31, 2015
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK870022
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS RECORD WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF MDRS TO IDENTIFY RECORDS IN WHICH AN EVENT OCCURRED, BUT THE TYPE OF REPORTABLE EVENT WAS NOT INDICATED APPROPRIATELY IN THE MDR FORM. THIS SUPPLEMENT IS BEING FILED TO MODIFY INFORMATION TO ALIGN WITH THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    INVESTIGATION: TERUMO BCT HAVE MADE MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL DETAILS OF THE EVENT, HOWEVER, THE PHYSICIAN DECLINED TO PROVIDE ANY INFORMATION SINCE IT WAS A BREACH OF CONFIDENTIALITY. NO FURTHER DETAILS OF THE EVENT WERE PROVIDED. THE LOT NUMBER FOR THIS EVENT WAS NOT PROVIDED, THEREFORE, A DEVICE HISTORY RECORD SEARCH COULD NOT BE CONDUCTED FOR THIS SPECIFIC INCIDENT. ALL LOTS MUST MEET ACCEPTANCE CRITERIA FOR RELEASE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE COULD NOT BE PROVIDED. BASED ON THE AVAILABLE INFORMATION,IT IS POSSIBLE THAT THE PATIENT¿S PRE-EXISTING CONDITIONS CONTRIBUTED TO THE CARDIAC ARREST AS INDICATED BY THE CUSTOMER¿S CONCERN PRIOR TO THE PROCEDURE.

    Additional Manufacturer Narrative · 1

    A MEDWATCH WAS RECEIVED FROM THE CUSTOMER ON 10/27/2015. (B)(4). THE DISPOSABLE SET WAS REQUESTED FOR FURTHER INVESTIGATION, HOWEVER, IT WAS NOT PROVIDED BY THE CUSTOMER. TERUMO BCT OFFERED TO SERVICE THE MACHINE TO CONFIRM IT WAS OPERATING AS INTENDED, HOWEVER, THIS OFFER WAS DECLINED BY THE CUSTOMER. ROOT CAUSE: THE DEFINITIVE CAUSE OF THE PATIENT'S DEATH WAS DETERMINED BY THE CUSTOMER'S MEDICAL PROFESSIONAL TO BE ATTRIBUTED TO CARDIAC AMYLOIDOSIS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE PATIENT WAS UNDERGOING A MONONUCLEAR CELL (MNC) COLLECTION PROCEDURE. SEVEN LITERS INTO THE PROCEDURE, THE PATIENT WENT INTO CARDIAC ARREST. THE TEAM WAS ABLE TO REVIVE HIM. HE WAS TRANSFERRED TO THE NEURAL INTENSIVE CARE UNIT (NICU) BUT HE LATER EXPIRED IN THE NICU. PER THE CUSTOMER, THE PATIENT HAD LOW BLOOD PRESSURE PRIOR TO STARTING THE PROCEDURE. PATIENT INFORMATION IS UNAVAILABLE AT THIS TIME. IT IS UNKNOWN AT THIS TIME IF THE DISPOSABLE SET IS AVAILABLE FOR RETURN.

    Description of Event or Problem · 1

    THE CUSTOMER DECLINED TO PROVIDE PATIENT INFORMATION FOR THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT'S AGE WAS OBTAINED FROM THE MEDWATCH FORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565743 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR