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

Catalog Number 12120

Device Problems Clumping in Device or Device Ingredient (1095); Increase in Pressure (1491); Obstruction of Flow (2423); Human-Device Interface Problem (2949)

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

Event Date 08/13/2018

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file was analyzed for this event.The signals in the d log along with the images indicate clumping during the run was likely the root cause for the multiple¿return pressure was too high¿ alarms.Images show signs of clumping around the same time the system began to receive the pressure alarms.This indicates that clumping was likely the cause of the alarms.The system received the, ¿high-level reservoir sensor detected excess fluid¿ alarm which occurs if the high reservoir level sensor sees fluid earlier than expected.This can typically occur if there is foaming in the reservoir, clumping in the reservoir, if the collect line is obstructed among other reasons.Clumping in the reservoir is likely the culprit for this procedure.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on aspecific platelet count and varies by patient.Therefore, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed in this location, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet: ac ratio to 8.The inlet: ac ratio was only decreased at the end of the procedure.As such, the clotting cascade had been activated and the clumping was likely more difficult to reverse.Consequently, it may have helped to use a lower inlet: ac ratio from the beginning of the procedure, and to reduce the inlet: ac ratio to 8 at the first signs of clumping.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that the device had return pressure high alarms during a spectra optiia mononuclear cell(mnc) collection procedure.The nurse observed clotting in several places in the disposable set, including the return line.The patient was disconnected and a second collection occurred the following day.Per the customer, no injury occurred to the patient.Patient identifier and date of birth are not available at this time.Patient gender and weight were obtained from the run data file (rdf).The optia collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: signals in the dlog along with the images indicate that it is possible, though not confirmed, that clumping during the run was contributed to the multiple ¿return pressure was too high¿ alarms.Images show signs of clumping around the same time the system began to receive the pressure alarms.This indicates that clumping was likely the cause of the alarms.The system received the, ¿high-level reservoir sensor detected excess fluid¿ alarm which occurs if the high reservoir level sensor sees fluid earlier than expected.This can typically occur if there is foaming in the reservoir, clumping in the reservoir, if the collect line is obstructed among other reasons.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.Therefore, every procedure should be observed for clumping in the connector and the collect port.If a clump is observed in this location, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.The inlet:ac ratio was only decreased at the end of the procedure.As such, the clotting cascade had been activated and the clumping was likely more difficult to reverse.Consequently, it may have helped to use a lower inlet:ac ratio from the beginning of the procedure, and to reduce the inlet:ac ratio to 8 at the first signs of clumping.

Event Description

Further follow up with the customer confirmed more details of the procedural events which included; the operator flushed the patient's ivc, it was noted to be sluggish but patent.The operator continued to receive high pressure alarms on the return line.The patient was recannulated but unable to continue the procedure.Rinseback was commenced by the registered nurse.The mononuclear cell (mnc) product was collected by the customer's stem cell lab scientist and terumo bct was informed that there were clots / thread-like deposits / fibrin clots in the product.The product was not usable and the patient would return for day 2 collection.Due to eu personal data protection laws, the patient information is not available from the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7856602
• MDR Text Key: 120109928
• Report Number: 1722028-2018-00243
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K172590
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Catalogue Number: 12120
• Device Lot Number: 1803023230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2018
• 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 Weight: 130