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

Model Number 12220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Output Problem (3005)

Patient Problem Hemolysis (1886)

Event Date 12/12/2021

Event Type  malfunction  

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.Per the customer the machine has not been in use since the procedure.Per the customer the patient had a kidney rejection and the hemolysis was noticed 5 minutes into the procedure in the cassette.The customer stated that they were able to end the procedure and use a different machine without any issues.The patient is reported as stable.Patient weight is unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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

Manufacturer Narrative

This report is being filed to provide additional information in a.4, h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.Per the customer the machine has not been in use since the procedure.Per the customer the patient had a kidney rejection and the hemolysis was noticed 5 minutes into the procedure in the cassette.The customer stated that they were able to end the procedure and use a different machine without any issues.The patient is reported as stable.The 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 in h.6 and h.10.Investigation: 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) was analyzed for this event.Run data file analysis was performed and there were no signs of hemolysis during the procedure.The aim system was disabled 3 minutes into the procedure, and the rbc detector showed no signs of hemolysis.The available aim system images also did not show any hemolysis.The procedure only ran for 8 minutes before it was terminated.The patient was stable.A disposable complaint history search was performed for this lot and found no other report for similar issues on this lot.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient's underlying disease state * patient's medication and/or medical treatment * hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.* hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.* hemolysis due to pinched return line resulting in rbc¿s exposed to pressure drop in return line.* hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.* hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.A root cause assessment was performed for this complaint.Based on the available information a definitive root cause for issue with the interface could not be determined but it is likely due to one or a combination of the possible causes listed below: * inaccurate entry of the patient's hematocrit.* channel was not properly loaded into the filler.

Event Description

The customer reported hemolysis during a therapeutic plasma exchange (tpe) procedure.Per the customer the machine has not been in use since the procedure.Per the customer the patient had a kidney rejection and the hemolysis was noticed 5 minutes into the procedure in the cassette.The customer stated that they were able to end the procedure and use a different machine without any issues.The patient is reported as stable.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• Manufacturer (Section D): TERUMO BCT; lakewood CO
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 13192801
• MDR Text Key: 287274587
• Report Number: 1722028-2022-00012
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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: 01/07/2022

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: 10/01/2023
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2110203130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 01/07/2022
• Supplement Dates Manufacturer Received: 06/27/2022; 06/27/2022
• Supplement Dates FDA Received: 02/01/2022; 06/27/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/20/2021
• 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: 42 YR
• Patient Sex: Male
• Patient Weight: 70 KG