MAUDE Adverse Event Report: TERUMO BCT TRIMA ACCEL; TRIMA PLT + SAMPLER, MULTIPLS, RBC

Model Number	82416
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
Event or Problem Description
The customer reported that they stopped the platelet collection procedure when they saw what appeared to be hemolysis.Per the customer, the product collected was extremely lipemic.The customers lab indicated the presence of hemolysis.The patient is stable and no medical intervention was required.Full id# (b)(6) the disposable set is not available for return.
Additional Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found another report 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.Multiple attempts were made to obtain the plasma free hemoglobin results but the customer did not respond to any of the requests.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.
Event or Problem Description
The customer reported that they stopped the platelet collection procedure when they saw what appeared to be hemolysis.Per the customer, the product collected was extremely lipemic.The customers lab indicated the presence of hemolysis.The patient is stable and no medical intervention was required.Full id# (b)(6) the disposable set is not available for return.

• Brand Name: TRIMA ACCEL
• Common Device Name: TRIMA PLT + SAMPLER, MULTIPLS, RBC
• 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: 14755278
• Report Number: 1722028-2022-00201
• Device Sequence Number: 12024428
• Product Code: GKT
• UDI-Device Identifier: 05020583824164
• UDI-Public: 05020583824164
• Combination Product (Y/N): N
• Initial Reporter State: HI
• Initial Reporter Country: US
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/01/2024
• Device Model Number: 82416
• Device Catalogue Number: 4824162
• Device Lot Number: 2203171162
• 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: 05/28/2022
• Supplement Date Received by Manufacturer: 07/15/2022
• Initial Report FDA Received Date: 06/21/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/17/2022
• 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 Age: 35 YR
• Patient Sex: Male