MAUDE Adverse Event Report: TERUMO BCT REVEOS; REVEOS PLATELET POOLING SET

Catalog Number 5419401

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: a used reveos platelet pooling set was received.The set was found to be assembled correctly with no kinks or leaks.Platelets were noted in the tubing both sides of the filter, no occlusions were identified.Investigation is in process, a follow-up report will be provided.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet pooling product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

Investigation: a used reveos platelet pooling set was received.The set was found to be assembled correctly with no kinks or leaks.Platelets were noted in the tubing both sides of the filter, no occlusions were identified.Normal saline was injected into the filter to check whether there was blockage and we confirmed that normal saline did not flow through the filter.After rinsing, we disassembled the filter to visually inspect the filter membranes and confirmed that the filter consisted of the main filter layers with three membranes, and it revealed no abnormalities.We observed the adhesion of blood in the first and second filter membranes from the inflow side of the filter.We dyed the filter membranes with toluidine blue and the results revealed that the first and second filter membranes from the inflow side were dyed darker.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.The other issue was not above the reportable limit.We reviewed the manufacturing record and the process inspection record of the part lot number in question (230518s2) and noticed no abnormalities.It was confirmed that the filter part lot was manufactured as per usual.We also reviewed the manufacturing record of particle removal rates of the filter membranes of the main filter layers, which could cause filter occlusion.The results revealed that they all conformed to the standards and no abnormalities were noticed.Root cause: a root cause assessment was performed for this complaint.As mentioned in the investigation results above, we did not observe any abnormalities in the filter concerned and it was confirmed in the manufacturing record that the filter concerned was within the quality standards.We therefore infer that the issues reported were not caused by the filters.As per the results of the analysis of the returned filter, we observed the adhesion of blood in the first and second filter membranes of the filter, and we confirmed that the filter media in was dyed darker with toluidine blue.From the results above, occlusion in the filter may have occurred due to the blood aggregates adhered to the filter media, and it resulted in a decrease of the filtration effective area.When the filtration effective area decreases, blood may be filtered by the filter area smaller than usual and it results in a fast linear speed (a flow rate per unit area) and possibly causes elevated rwbc level.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet pooling product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Event Description

The customer would like the run data file investigated to determine a possible cause for the elevated white blood cell (wbc) content in the platelet pooling product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in b.6 and d.4.Investigation: a used reveos platelet pooling set was received.The set was found to be assembled correctly with no kinks or leaks.Platelets were noted in the tubing both sides of the filter, no occlusions were identified.We received filters and performed the following investigations.Normal saline was injected into the filter to check whether there was blockage and we confirmed that normal saline did not flow through the filter.After rinsing, we disassembled the filter to visually inspect the filter membranes and confirmed that the filter consisted of the main filter layers with three membranes, and it revealed no abnormalities.We observed the adhesion of blood in the first and second filter membranes from the inflow side of the filter.We dyed the filter membranes with toluidine blue and the results revealed that the first and second filter membranes from the inflow side were dyed darker.We reviewed the manufacturing record and the process inspection record of the part lot number in question (230518s2) and noticed no abnormalities.It was confirmed that the filter part lot was manufactured as per usual.We also reviewed the manufacturing record of particle removal rates of the filter membranes of the main filter layers, which could cause filter occlusion.The results revealed that they all conformed to the standards and no abnormalities were noticed.Root cause: as mentioned in the investigation results above, we did not observe any abnormalities in the filters concerned and it was confirmed in the manufacturing record that the filters concerned were within the quality standards.We therefore infer that the issues reported were not caused by the filters.As the results of the analysis of the returned filters, we observed the adhesion of blood in the first and second filter membranes of the filter, and we confirmed that the filter media in both filter were dyed darker with toluidine blue.From the results above, occlusion in the filters may have occurred due to the blood aggregates adhered to the filter media, and it resulted in a decrease of the filtration effective area.When the filtration effective area decreases, blood may be filtered by the filter area smaller than usual and it results in a fast linear speed (a flow rate per unit area) and possibly causes elevated rwbc level.

• Brand Name: REVEOS
• Type of Device: REVEOS PLATELET POOLING SET
• 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: 18444736
• MDR Text Key: 331902752
• Report Number: 1722028-2024-00003
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: BK230838
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 01/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5419401
• Device Lot Number: 2308181251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/02/2023
• 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