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

Catalog Number 12120

Device Problems Clumping in Device or Device Ingredient (1095); Coagulation in Device or Device Ingredient (1096); Human-Device Interface Problem (2949)

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

Event Date 08/02/2018

Event Type  malfunction  

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 customer provided clinical data and pictures in lieu of the disposable set to further aid in the investigation.The pictures confirmed the presence of large clots in the collection bag.The procedure run sheet indicated that 2 750 ml acda bags were used.Investigation is in process, follow-up information will be provided.

Event Description

The customer reported that at the end of a run during an autologous mononuclear cell (mnc)collection procedure on spectra optia, they noticed some clotting in the blood warmer tubing set.Per the customer, no medical intervention was required.The customer declined to provide patient identifier and age.Patient gender and weight were obtained from the run data files.Patient outcome is not available at this time.The spectra optia collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide a correction and additional information.Investigation: terumo bct national clinical manager later received a confirmation from the customer that the operator saw clots in the blood warmer tubing and not in the vascath.The clinical data included the patient's pre counts and coagulation results.Prothrombin (pt), activated partial thromboplastin time (aptt) and international normalized ratio (inr) appeared to be within normal ranges for an individual who is not on blood thinner regimen.Run summary: collect bag volume: 276ml plasma volume in collect bag: 93ml; plasma bag volume: 0ml; procedure time: 299 min; fluid balance: 122%, patient blood volume processed: 13785ml; tbv processed: 3.23.Root cause: signals in the dlog along with the images do not indicate a conclusive root cause for the clotting that was identified during the procedure.Images do show some signs of clumping in the connector, there were also reservoir alarms and the ¿volume in collection bag may be lower than reported¿ can also be associated with clumping.There were also several ¿return pressure was too high¿ alarms.The system received several different alarms indicating that the amount of fluid entering the reservoir was more than expected.The ¿low-level reservoir sensor detected excess fluid¿ alarm occurs if the lower reservoir level sensor does not see air within when the system calculates there should only be 5 ml of fluid remaining in the reservoir.This can typically occur if there is foaming in the reservoir, clumping in the reservoir, if the collect line is obstructed.There was also an occurrence of the ¿volume in collection bag may be lower than reported¿ alarm.This alarm occurs if the system detects that the reservoir volume error is more than 50% of the collected volume.Typical cause of this alarm is an occlusion of the collect line.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 not decreased throughout the entire procedure.As such, the clotting cascade may have 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.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECTION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7823146
• MDR Text Key: 118758779
• Report Number: 1722028-2018-00227
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Catalogue Number: 12120
• Device Lot Number: 1710203330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 09/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2017
• 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: 56