MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA COLLECTION SET

Catalog Number	10120
Health Effect - Clinical Code	Death (1802)
Date of Event	09/13/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation: the rdf was analyzed for this event.Review of the rdf does not show any indications of any issues during the procedure that would have contributed to the patient's death.Signals from the dlog showed no unusual alarms or abnormal procedure behavior.Given this information, there were no signals in the dlog that would indicate the machine did not operate as intended.The system was operating within the safety limits programmed in the machine.The device was found to be operating as intended, and within the generally tolerated limits for the majority of patients.There was no system or device malfunction identified that would indicate an issue with the optia system.The optia system appeared to be operating as intended and is safe to use.Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that post a mono nuclear cell (mnc) collection on the spectra optia, the patient expired.Per the customer, they are unsure if the death was related to the procedure.The patient's vascular access was a central line.Patient age is not available at this time.The patient's gender was obtained from the run data file (rdf).The lot number, manufacture date and expiry date are not available at this time.The spectra optia collection set is not available for return because it was discarded by the customer.This report is being filed due to patient death, although per current information there is no suspected malfunction with the terumo bct device or allegation of a malfunction.
Additional Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.
Event or Problem Description
Per customer, no autopsy was not performed on the patient.
Additional Manufacturer Narrative
This report is being filed to provide corrected udi and additional information and investigation: the disposable set was not available for return.A full system checkout was performed on nov 13, 2018.The inspection confirmed that there was no device malfunction, and the device was released for use.Root cause: review of the d log does not show any indications of any issues during the procedure that would have contributed to the patient's death.Signals from the d log showed no unusual alarms or abnormal procedure behavior.Given this information, there were no signals in the d log that would indicate the machine did not operate as intended.The system was operating within the safety limits programmed in the machine.The device was found to be operating as intended, and within the generally tolerated limits for the majority of patients.There was no system or device malfunction identified that would indicate an issue with the optia system.The optia system appeared to be operating as intended and is safe to use.The physician treated the patient confirmed that the cause of death was due to lung embolism related to the patient's disease state.Per terumo bct's medical review, the device did not cause or contribute to this incident.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA COLLECTION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 7949911
• Report Number: 1722028-2018-00281
• Device Sequence Number: 1301815
• Product Code: GKT
• UDI-Device Identifier: 05020583101104
• UDI-Public: 05020583101104
• Combination Product (Y/N): N
• Initial Reporter Country: MA
• PMA/510(K) Number: K153601
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/01/2018
• Device Catalogue Number: 10120
• Device Lot Number: 09Z3128
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 11/02/2018; 11/16/2018
• Initial Report FDA Received Date: 10/09/2018
• Supplement Report FDA Received Date: 11/02/2018; 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 42 YR
• Patient Weight: 47