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

Catalog Number 12320

Device Problems Complete Blockage (1094); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/15/2019

Event Type  Injury  

Manufacturer Narrative

Lot number, manufacture date and expiry date are not available at this time.Investigation: a terumo bct service technician checked out the machine at the customer site.Pump rotor occlusions and machine pressure transducers were checked and found to be within manufacturer specifications.An auto test and simulated treatment were successfully run and no problems were found.The run data file (rdf) was analyzed for this event.Review of the aim images revealed that some clumping on the interface was present during the last hour of the run.The inlet:ac ratio was set to 12:1 and was never changed to address the clumping.Based on the signals seen in the run data file, the optia device operated as intended.A review of the device history record (dhr) for this acda lot showed no irregularities during manufacturing that were relevant to this issue.Sterility assurance report was completed and batch found to be satisfactory.All chemistry and microbiological results compliant snd sterilization parameters were met.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a multiple myeloma patient was undergoing a continuous mononuclear cell (cmnc) collection procedure on a spectra optia device.Approximately 15 minutes after they had clamped the product off and began to walk the product down the stem cell lab the product bag clotted off.Per the customer, no clumping or clotting was seen during the run and they used 4 bags of acda.The clot was visualized after heat sealing the product off and laying it down for labeling post rinse back.The customer reported they noticed the product seemed spongy and turned it over, that is when they noticed there was a large clot in the collection bag surrounded by fluid.As a result of the loss of product, the patient had to continue mobilization for stem cell collection via neupogen 300 mcg sq and mozobil 2400 mcg sq.The additional mobilization was not planned as this would have been the last day of collection to complete the desired target from day 1 and day 2 collections.The customer reported that the patient is in stable condition.Patient id is not available at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer declined to provide the patient identifier.

Manufacturer Narrative

This report is being filed to provide in investigation: the customer submitted pictures in lieu of the set.The picture confirmedsignificant clumping within the product bag as described by the customer.The reported lot for the acda was reviewed and there were no other complaints for this lotnumber found.Root cause: based on the clinical findings and run data file analysis, a specific root cause for theclumping in the product could not be determined.Possible causes include, but are not limited to:- the inlet/anti-coagulant ratios used in the procedure were inadequate to keep theextracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.- activation of platelets as a result of the patient's physiology.- frangible on the correct connect was not properly broken after connecting the subsequentacda bags.- ac line was obstructed after initial acda connection.- operator did not follow screen prompts for properly addressing alarms which occurredthroughout the procedure.

Manufacturer Narrative

This report is being filed to provide in investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8679586
• MDR Text Key: 148451869
• Report Number: 1722028-2019-00137
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1902143230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 05/15/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 08/08/2019; 08/22/2019
• Supplement Dates FDA Received: 08/16/2019; 08/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00057 YR
• Patient Weight: 133