MAUDE Adverse Event Report: TERUMO BCT REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM; 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 12/01/2023

Event Type  malfunction  

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.The platelet collection set is not available for return because it was discarded by the customer.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 is in process, a follow-up report will be provided.

Manufacturer Narrative

Investigation: we confirmed that the information of the elevated rwbc levels as described.We then received filters and performed the following investigations.Product lot no.2307281251 normal saline was injected into the filter to check whether there was blockage and we confirmed that normal saline flowed through the filter slowly at a rate of about 5 ml/min.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 that the membranes were incorporate into the housing without abnormality.We observed the adhesion of blood in the first filter membrane from the inflow side of the filter.We dyed the filter membranes with toluidine blue and the results revealed that the lower part of the filer media (the inlet part) of the first through third filter membranes from the inflow side were dyed darker.We also noticed the evidence of residual air (air spots).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 filter membrane from the inflow side of the filter of product lot no.2307281251, and we confirmed that the filter media in both filter were dyed darker with toluidine blue.It was also confirmed that the evidence of residual air was observed in the filter of product lot no.2307281251.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.

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 with a bag of platelet additive solution (pas) attached was received for investigation.The set was found to be assembled correctly with no kinks.The interim platelet unit (ipu) bags were not returned.Platelets were noted on both sides of the filter.Normal saline was injected into the filter to check whether there was blockage and we confirmed that normal saline flowed through the filter slowly at a rate of about 5 ml/min.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 that the membranes were incorporate into the housing without abnormality.We observed the adhesion of blood in the first filter membrane from the inflow side of the filter.We dyed the filter membranes with toluidine blue and the results revealed that the lower part of the filer media (the inlet part) of the first through third filter membranes from the inflow side were dyed darker.We also noticed the evidence of residual air (air spots).A pooled platelet product was collected with elevated rwbc result of 24 x106 cells per unit.The product was tested using flow cytometry and was not used by the customer.The customer reported a filtration time that was long than usual and a normal platelet count.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.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Corrected 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 issue reported was not caused by the filter.As the results of the analysis of the returned filter, we observed the adhesion of blood in the first filter membrane from the inflow side of the filter, and we confirmed that the filter media in were dyed darker with toluidine blue.It was also confirmed that the evidence of residual air was observed in the filter.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.

• Brand Name: REVEOS AUTOMATED WHOLE BLOOD PROCESSING SYSTEM
• 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: 18403483
• MDR Text Key: 331548668
• Report Number: 1722028-2023-00423
• 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: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2023
• 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: 2307281251
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• 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