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

Catalog Number	10300
Health Effect - Clinical Code	Death (1802)
Date of Event	12/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Investigation: the customer did not provide the lot number pertaining to this event; therefore, a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The customer did not provide the device serial number; therefore, a service call could not be performed to verify that there was no "machnine" malfunction.Lot number, manufacture date and expiry are not available per the customer.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that while undergoing an emergency white blood cell depletion (wbcd) procedure,the patient expired due to a heart attack.The customer is not alleging any problem with the machine or the wbcd set and is "considering to" be due to the patient¿s medical condition at the time.Due to eu personal data protection laws, the patient information is not available from 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.The customer declined to provide any information for the investigation such as procedural details, set information and lot information.
Additional Manufacturer Narrative
This report is being filed to provide corrected information.Investigation is in process.A follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information.Root cause: per the customer's statements and description of events, the cause of death during the wbcd procedure was cardiac arrest due to the patient's medical condition.Per terumo bct medical review, there is no current evidence to suggest that the device caused or contributed to the patient's death.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8199598
• Report Number: 1722028-2018-00362
• Device Sequence Number: 16562240
• Product Code: GKT
• UDI-Device Identifier: 05020583101104
• UDI-Public: 05020583101104
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K172590
• 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): 12/27/2018

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 Catalogue Number: 10300
• 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: 12/27/2018
• Supplement Date Received by Manufacturer: 12/27/2018; 02/11/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 12/27/2018; 02/12/2019
• 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