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

Catalog Number 10310

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802)

Event Date 10/18/2018

Event Type  Death  

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.The run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the spectra optia system operated as intended.Per the physician's statement, the cause of death was cardiopulmonary arrest due to shock,leading to multiorgan disfunction, with cml leukostasis, confirming the death of the patient was unrelated to the procedure.A terumo bct service technician visited the customer's site and performed a machine checkout.Upon inspection, there were no concerns noted.Investigation is in process.A follow-up report will be provided.

Event Description

The customer contacted a terumo bct clinical specialist for assistance in calculating a white blood cell depletion (wbcd) using continuous mononuclear cell (cmnc) collection.Per the customer, they wanted to perform a white blood cell depletion (wbcd) on the patient, however, the machine being used did not have the wbcd protocol, so they used the cmnc protocol instead.The customer was called back to see how the procedure went and the customer informed terumo bct that the cmnc procedure lasted 198 minutes and the patient died several hours after the procedure.The customer stated that they could not release the autopsy results.The spectra optia exchange set is not available for return because it was discarded by the customer.The customer declined to provide the patient identifier.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.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the customer initially contacted terumo bct support specialist to calculate the collect flowrate (cfr) for a white blood cell depletion (wbcd) procedure using a continuous mononuclearcell (cmnc) collection protocol.The customer was advised to lower the inlet flow rate to 34 or 35 and the cfr calculated to 9.7 and 10.The reason not to increase the inlet flow rate was also explained to the customer.The customer further informed that they were not able to confirm the run screen as the total blood volume (tbv) entered was twice the amount.The support specialist suggested to lower the tbv to 1.2 and received confirmation of the runscreen.The customer stated they will discuss the processed replacement fluid and the tbv with the physician.During customer follow-up on 10/19/18, the customer stated that the patient had expired.The rdf was analyzed for this event.The signals in the rdf indicated that total 8 alarms were experienced.The operator was able to continue through the alarms and completed the procedure.The procedure was performed smoothly.The machine performed per the specifications and designs and completed the procedure while simultaneously keeping the patientsafe.Per terumo bct medical safety review, the device did not cause or contribute to this event.Root cause: per the physician's statement and the additional information provided by the customer, the rdf, dhr review, and the service call, the optia device is not the cause of the patient death.In addition, the customer also stated that the death was not due to a malfunction of the system.The physician determined that the patient's death was a result of the underlying disease, cml with complications of cardiopulmonary arrest due to shock leading to multiorgan dysfunction.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 8055597
• MDR Text Key: 126722735
• Report Number: 1722028-2018-00301
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2020
• Device Catalogue Number: 10310
• Device Lot Number: 1809053130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00048 YR
• Patient Weight: 78