BEUDAMED
    FDA Adverse Event Death Summary report: N

    COBE SPECTRA BLOOD COLLECTION

    MDR report key: 4913747 · Received July 14, 2015

    Report

    Report Number
    1722028-2015-00254
    Event Type
    Death
    Date Received
    July 14, 2015
    Date of Event
    April 7, 2014
    Report Date
    June 19, 2015
    Manufacturer
    TERUMO BCT
    Product Code
    GKT
    PMA / PMN Number
    BK080035
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION: THE DISPOSABLE SET WAS UNAVAILABLE FOR FURTHER EVALUATION REGARDING THE LOW MNC YIELD. AFTER MULTIPLE COMMUNICATION ATTEMPTS NO FURTHER INFORMATION REGARDING THE DEATH OF THE PATIENT,THE MACHINE ON WHICH THE DEATH SUPPOSEDLY OCCURRED, OR ANY POTENTIAL CAUSE OF THE ALLEGED DEATH COULD BE OBTAINED. THE CUSTOMER WAS CONTACTED IN AN EFFORT TO OBTAIN INFORMATION REGARDING THE PATIENT THAT HAD REPORTEDLY PASSED AND THE PROCEDURE THAT HAD BEEN PERFORMED. THIS INFORMATION WAS UNAVAILABLE FROM THE CUSTOMER THAT HAD ORIGINALLY REPORTED IT. ATTEMPTS WERE MADE TO IDENTIFY THE PATIENT USING THE DONOR¿S INFORMATION. ALTHOUGH THIS INFORMATION WAS REQUESTED, THE CUSTOMER COULD NOT PROVIDE IT AS THE DONOR¿S FILES WERE NO LONGER ACCESSIBLE. ADDITIONAL ATTEMPTS TO SPEAK WITH A NMDP ASSOCIATE WHO MIGHT BE ABLE TO PROVIDE IDENTIFYING INFORMATION WERE ALSO UNSUCCESSFUL. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THIS UNIT SHOWED NO IRREGULARITIES DURING MANUFACTURING THAT WERE RELEVANT TO THIS ISSUE. ROOT CAUSE: A DEFINITIVE ROOT CAUSE FOR THE LOW YIELD COULD NOT BE DETERMINED. A LOW YIELD CAN BE CAUSED BY, BUT NOT LIMITED TO, FREQUENT PAUSES IN THE PROCEDURE, THE DONOR¿S PHYSIOLOGY, OR INACCURATE DONOR COUNTS. THE CAUSE OF THE ALLEGED DEATH COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION: AFTER MULTIPLE COMMUNICATION ATTEMPTS, NO FURTHER INFORMATION WAS PROVIDED BY THE CUSTOMER REGARDING THE CIRCUMSTANCES OR POTENTIAL CAUSE OF THE PATIENT'S DEATH. ALL REPORTS RELATED TO SPECTRA SINCE 2013 WERE REVIEWED AND THERE WERE NO INCIDENTS WHERE A LOW-YIELD DONATION CONTRIBUTED TO A PATIENT'S DEATH. PER INTERNAL MEDICAL REVIEW, THERE IS NO INDICATION THAT SPECTRA CAUSED OR CONTRIBUTED TO THE PATIENT'S DEATH. THE PROBABILITY OF DELAYED OR NON-ENGRAFTMENT IS HIGH IF ONLY 0.51X10^6/KG CD34 CELLS ARE TRANSPLANTED FOLLOWING MARROW ABLATIVE THERAPY, HOWEVER, IT WOULD BE HIGHLY UNUSUAL FOR A TRANSPLANT CONSISTING OF SO FEW CD34 CELLS TO BE GIVEN. IT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE WHETHER ADDITIONAL CELLS WERE TRANSPLANTED. UPDATED ROOT CAUSE: THE CAUSE OF THE ALLEGED RECIPIENT DEATH COULD NOT BE DETERMINED BASED ON THE INFORMATION AVAILABLE. THERE IS NO EVIDENCE INDICATING THAT SPECTRA CAUSED OR CONTRIBUTED TO THE RECIPIENT'S DEATH.

    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: AT THE TIME THE CUSTOMER REPORTED THE BONE MARROW RECIPIENT DEATH TO TERUMO BCT, THEY ALSO MENTIONED THAT THERE WAS A LOWER THAN EXPECTED YIELD FOR THE MARROW COLLECTION. DONOR WBC: 54X10^6, PLATELET: 169X10^3, PRE CD34: 74.88/UL. THE TARGET YIELD WAS 5.0X10E6 (B)(4), BUT TOTAL (B)(4) COLLECTED WAS 0.51X10E6/KG. THE DATE OF THE COLLECTION WAS (B)(6) 2014 AND THE TERUMO BCT NOTIFICATION DATE WAS IN (B)(6) OF 2015. THE MACHINE RECEIVED ITS SEMI-ANNUAL PREVENTATIVE MAINTENANCE (PM) SERVICE IN (B)(6) 2015 AND NO ABNORMALITIES WERE NOTED.

    Description of Event or Problem · 1

    THE CUSTOMER DID NOT PROVIDE THE PATIENT'S OR DONOR'S INFORMATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE RECIPIENT OF A (B)(6) COLLECTED ON A COBE SPECTRA SYSTEM HAD EXPIRED. THE DATE THAT THE RECIPENT EXPIRED IS UNAVAILABLE AT THIS TIME. PATIENT (RECIPIENT) INFORMATION IS UNAVAILABLE AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    457447 COBE SPECTRA BLOOD COLLECTION COBE SPECTRA WHITE BLOOD CELL SET GKT TERUMO BCT 01W15276

    Patients

    Seq Age Sex Outcome Treatment
    1