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

Model Number 10220

Device Problems Improper Flow or Infusion (2954); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemolysis (1886); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/06/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they had several 'cells were detected in plasma line from centrifuge' alarms at the beginning of a red blood cell exchange (rbcx) procedure using a spectra optia device.The operator noticed the replacement fluid wasn't going in and reported that the interface was all red.The customer told terumo bct customer support that the hematocrit entered was 26.3% and it was from yesterday.Tbct customer support had the customer increase the hematocrit to 29%.The customer retried the procedure and got the same alarms.A photo was sent to tbct customer support of the interface and it was seen that it was plasma, not red cells.Tbct customer support had the operator pause the procedure and notify the physician.The customer started a saline drip.The customer confirmed the fluids hanging were appropriate.The physician was not available by phone within 3-5 minutes and the operator felt uncomfortable waiting, the patient was disconnected from the device to allow them to figure out what the issue was with the patient's blood.The patient was in fair condition following the procedure.The patient complained of weakness and pain prior to start of procedure.The customer declined to provide patient identifier.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.5.Investigation is in process.A follow up report will be provided.

Event Description

Hemolysis testing was not performed.The patient had another procedure the next day without complications.The physicians did not respond with any feedback.

Manufacturer Narrative

Investigation: photographs of the interface through the viewport and the cassette were provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.No obvious misassemblies, kinks, or "occlusion" can be observed in the provided images.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) confirmed that the first 'cells were detected in plasma line from centrifuge' alarm occurred at 4.8 minutes.There was a total of 10 cells detected alarms during the procedure.There were no inlet pressure low, centrifuge pressure high or level sensor alarms that are consistent with occlusions, clotting that would have resulted in fluid diversion.This suggests that the hemolysis was likely related to the patient's underlying disease.The patient's tbv was 4800 so a custom prime was not performed.This was ruled out as a possible source of hemolysis.Root cause: a definitive root cause for the discolored plasma could not be determined.Possible causes include but are not limited to: the patient's underlying disease state.A misload of the disposable set; occlusion in the disposable set tubing; partial flash, bad seam weld, and/or assembly error on the channel connector.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11237493
• MDR Text Key: 259340170
• Report Number: 1722028-2021-00048
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/27/2021

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 Expiration Date: 10/01/2022
• Device Model Number: 10220
• Device Catalogue Number: 10220
• Device Lot Number: 2010163230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/27/2021
• Supplement Dates Manufacturer Received: 03/19/2021; 08/01/2022
• Supplement Dates FDA Received: 04/06/2021; 08/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2020
• 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 Age: 00029 YR
• Patient Sex: Male
• Patient Weight: 81 KG