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

Catalog Number 12220

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 11/08/2019

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and images associated with this complaint do not show a conclusive root cause for the reservoir alarms that occurred during this procedure.Review of the images do show some signs of clumping/platelet aggregation in the connector and could be a possible reason for the reservoir alarms occurring during this procedure.The operator received 3 different reservoir alarms during this procedure: low-level reservoir sensor did not detect fluid: this alarm occurs if the system detects air at the lower level sensor when it is still expecting fluid.High-level reservoir sensor detected excess fluid alarm: this alarm occurs if the system detects fluid at the upper level sensor when it is expecting air.Reservoir sensors malfunctioned alarm: this alarm occurs if the high-level sensor saw fluid but low-level sensor did not, or neither sensor saw fluid while flow model suggests fluid should be in reservoir.This could occur if a clot gets stuck over the lower-level sensor and tricks the system into thinking that there is fluid in the lower level sensor and may also happen if there is excess foaming in the reservoir.Aside from the alarms displayed, the images also showed signs of clumping.Clumping was identified in the images from the aim system.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, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.Once a clump has been resolved, a ratio that maintains adequate separation should be used.If the clump persists in a procedure it can clot off the set and cause flow restrictions and occlusions.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that a procedure was ended when air was detected in the reservoir on an exchange procedure on a spectra optia device.Per the customer the device only gave the disconnect patient option.Per the customer they could not remove the air from the return line to continue the procedure.Patient identifier, age and outcome are unknown at this time.Patient gender and weight were obtained from the run data file (rdf).The disposable set is not available for return because it was discarded by the customer.

Event Description

Upon follow up with the customer it was confirmed that there was no ill effect to the patient and they did not require medical intervention for this event.The customer declined to provide the patient identifier and age.

Manufacturer Narrative

Investigation: the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Root cause: review of the rdf and images associated with this complaint do not show a conclusive root cause for the reservoir alarms that occurred during this procedure.Review of the images do show some signs of clumping/platelet aggregation in the connector and could be a possible reason for the reservoir alarms occurring during this procedure.The operator received 3 different reservoir alarms during this procedure: 1) low-level reservoir sensor did not detect fluid: this alarm occurs if the system detects air at the lower level sensor when it is still expecting fluid.2) high-level reservoir sensor detected excess fluid alarm: this alarm occurs if the system detects fluid at the upper level sensor when it is expecting air.3) reservoir sensors malfunctioned alarm: this alarm occurs if the high-level sensor saw fluid but low-level sensor did not, or neither sensor saw fluid while flow model suggests fluid should be in reservoir.This could occur if a clot gets stuck over the lower-level sensor and tricks the system into thinking that there is fluid in the lower level sensor and may also happen if there is excess foaming in the reservoir.Aside from the alarms displayed, the images also showed signs of clumping.Clumping was identified in the images from the aim system.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, it is best to eliminate it and stop the clotting cascade as quickly as possible by reducing the inlet:ac ratio to 8.Once a clump has been resolved, a ratio that maintains adequate separation should be used.If the clump persists in a procedure it can clot off the kit and cause flow restrictions and occlusions.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9401972
• MDR Text Key: 187444574
• Report Number: 1722028-2019-00390
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 11/08/2019
• Initial Date FDA Received: 12/03/2019
• Supplement Dates Manufacturer Received: 01/24/2020
• Supplement Dates FDA Received: 01/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 75