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

Catalog Number 000000000000010120

Device Problems Clumping in Device or Device Ingredient (1095); Positioning Failure (1158); Leak/Splash (1354); Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Disseminated Intravascular Coagulation (DIC) (1813); Renal Failure (2041)

Event Date 09/05/2014

Event Type  Death  

Event Description

The customer reported that a primate expired 2 days after a mononuclear cell (mnc) collection procedure.The customer stated that during the procedure on (b)(6) 2014, they had some access issues and some clumping in the inlet manifold, then a leak detected alarm that they couldn't clear.They kept the animal anesthetized by gas and he recovered after the procedure, but was 'off'.He went into acute renal failure and disseminated intravascular coagulation (dic) and expired on (b)(6) 2014.The customer is not alleging a deficiency with the disposable set or device.The disposable kit is not available for return because it was discarded by the customer.This report is being filed due to a patient ((b)(6)) death, though at this time, the device is not suspected or alleged to be a contributory factor in the death.

Manufacturer Narrative

Investigation: an internal investigation has been initiated at the customer's site.The customer stated that they are investigating if the (b)(6) had any pre-disposing issues that would have caused the death.The customer requested for re-training on the spectra optia machine.Terumo bct service representative performed a full functional check, including the leak detector, on the spectra optia device with no discrepancies found.The problem could not be duplicated during checkout.The run data file (rdf) was analyzed for this event.There were several alarms during this procedure which are not uncommon to occur during procedures on small patients with a small total blood volume.As the procedure progressed the system predicted that the fluid balance limits would be exceeded based on the currently entered patient information and run values, and required operator confirmation in order to continue with the collection.The signals in the run data file indicate that the spectra optia system operated as intended and is safe to use.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Retraining to the mnc protocol was performed by a terumo bct clinical specialist on (b)(6) of 2014.Root cause: the cause of death about 48 hours post-procedure was stated by the customer to be acute renal failure and dic.The spectra optia machine did not likely contribute to the death of the primate.The inlet pressure too low alarms can be, but not exclusively, caused by clotting or adequate line access.

Manufacturer Narrative

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 in to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4157319
• MDR Text Key: 16086504
• Report Number: 1722028-2014-00411
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 000000000000010120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00008 YR
• Patient Weight: 8