MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA ACCEL PLT, PLASMA, ISBT

Catalog Number	5803002
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process and a follow-up report will be provided.
Event or Problem Description
The customer reported that after completing an apheresis platelet procedure on a trima device, the operator noticed that the collected platelet product looked red.The operator tested the product and found that the free hemoglobin content was high.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.
Event or Problem Description
The customer reported that after completing an apheresis platelet procedure on a trima device, the operator noticed that the collected platelet product looked red.The operator tested the product and found that the free hemoglobin content was high.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide addtional information in h.6 and h.11.Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.The photograph shows used primary and secondary platelet bags, and associated tubing, from a trima accel disposable set.The photograph confirms the presence of a red tinge.No kinks or misassemblies are visible.A disposable complaint history search was performed for this lot and found zero reports for similar issues on this lot.Investigation is in process and a follow-up report will be provided.
Event or Problem Description
The customer reported that after completing an apheresis platelet procedure on a trima device, the operator noticed that the collected platelet product looked red.The operator tested the product and found that the free hemoglobin content was high.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The platelet collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.The photograph shows used primary and secondary platelet bags, and associated tubing, from a trima accel disposable set.The photograph confirms the presence of a red tinge.No kinks or misassemblies are visible.A disposable complaint history search was performed for this lot and found zero reports for similar issues on this lot.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 and a follow-up report will be provided.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.11.The customer declined to provide the customer's contact name or title.Investigation: a photograph was submitted in lieu of the disposables set to aid in the investigation.The photograph shows used primary and secondary platelet bags, and associated tubing, from a trima accel disposable set.The photograph confirms the presence of a red tinge.No kinks or misassemblies are visible.A disposable complaint history search was performed for this lot and found zero reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * donor susceptibility causing low level hemolysis in the platelet and plasma products.* high shear rates on a platelet (white stamp) disposable set resulting in hemolyzed blood back to donor due to one of the following causes: inappropriate needle gauge (sterile doc at customer or misassembly in manufacturing); occlusion or kinks in lines; return line occlusion; high hematocrit in needle, rbc line; loop vibration; centrifuge imbalance; needle flow rate too high; manufacturing defects (flashing, excess header lengths); failures in the control system cause high hematocrit in the reservoir.* rbc line occlusion causes backpressure in rbc line forcing blood to take alternate route to reservoir resulting in blood damage.
Event or Problem Description
The customer reported that after completing an apheresis platelet procedure on a trima device, the operator noticed that the collected platelet product looked red.The operator tested the product and found that the free hemoglobin content was high.There was not a transfusion recipient or patient involved at the time of the unit processing, therefore no patient information is reasonably known at the time of the event.The customer declined to provide further patent or procedural details such as hemolysis testing (plasma hemoglobin and/or percent hemolysis).The platelet collection set is not available for return because it was discarded by the customer.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA ACCEL PLT, PLASMA, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• 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: 18964780
• Report Number: 1722028-2024-00095
• Device Sequence Number: 8052631
• Product Code: GKT
• UDI-Device Identifier: 05020583803008
• UDI-Public: 05020583803008
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: BK190332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/22/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2025
• Device Catalogue Number: 5803002
• Device Lot Number: 2310134151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2024
• Supplement Date Received by Manufacturer: 05/21/2024; 06/04/2024; 07/05/2024
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/03/2024; 06/28/2024; 07/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/11/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown