MAUDE Adverse Event Report: TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER

Catalog Number 1BBLGQ506A6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/02/2024

Event Type  malfunction  

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.Donor unit id #: (b)(6) 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.

Manufacturer Narrative

Investigation: we have not received the set returned from the customer.We therefore performed investigation based on the provided information.In making the blood bags concerned, sealed bags are filled with solution, the line is assembled, and sterilized by automated equipment.These bags are stacked and placed into the blister packs by workers then the top film of each blister pack is heat-sealed.In making leukocyte reduction filters, filter membranes are punched, overlayed, and put in filter housings.These leucocyte reduction filters are then assembled into the products in the above-mentioned manufacturing process.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates of filter membranes.The membranes that have conformed to the standards are used in the assembling process.We reviewed the manufacturing process and the record of filter membrane manufacture.There were no equipment trouble/problems and we confirmed that the filter membranes conformed to all standards.Release testing, which includes measurements of solution concentration and volume and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the production number and confirmed that there were no anomalies in all release testing items.The product conformed to the standards.Regarding the retained sample of the lot number concerned, three sets were visually inspected.There were not any occlusions in tubing, blocking, or any abnormalities in their appearances.Root cause: from the above-mentioned investigation results, we did not observe any abnormalities in the manufacturing process of the lot number concerned.As mentioned in the investigation results above, the filter membranes of the product concerned consist of a rough-pore pre-membrane (the first filter membrane) and minute-pore main membranes (the second through eighth filter membranes).According to the data at the time of designing of the product in question, there is a possibility of white blood cell contamination when the particulate removal rates are low.However, as mentioned above, the particulate removal rates of the lot number concerned were within the standards and did not show a low tendency.Therefore, we were not able to identify the cause of the event.Leukoreduction failure is commonly caused by the following factors: 1) analysis affected by blood properties of donors the following blood properties or blood conditions on blood collection may cause wbc count failures.For the details, please refer to the excerpt from the literature.Spurious counts and spurious results on wbc counts (spurious increase) platelet aggregates / large platelets nucleated red blood cells rbc resistant to lysis immunoglobulin lipids microorganisms / bacterial aggregates zandecki m, genevieve f, gerard j, godon a.Spurious counts and spurious results on haematology analyzers: a review.Part ii: white blood cells, red blood cells, hemoglobin, red cell indices and reticulocytes.International journal of laboratory hematology.2007, 29, 21¿41, table 1.2) pressure loaded on filter membranes where a physical stress on filter membranes is greater than what is expected, trapped white blood cells are pushed out of the filter membranes and may result in leukoreduction failure.For the prevention of leukoreduction failure, the instructions for use (ifu) of the product state: "[caution] do not squeeze or apply pressure on the filter while it is attached to the bag containing the filtered blood".

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.Donor unit id #: (b)(6) 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.

Manufacturer Narrative

Investigation: we received one set of the blood bags (unit id no.(b)(6)).The following investigations were performed: we injected 570 ml of normal saline into the collection bag and observed that normal saline slowly flowed through the filter.The flow rate was about 8 ml/min.Following rinsing the filter with normal saline, we disassembled the filter and confirmed that abnormalities such as detached and misaligned filter membranes were not observed in the filter.The number of filter membranes in the filter conformed to the specifications.We dyed the rinsed filter membranes with toluidine blue.It was confirmed that the first through third filter membranes from the inlet side of the filter was dyed darker with toluidine blue.In making the blood bags concerned, sealed bags are filled with solution, the line is assembled, and sterilized by automated equipment.These bags are stacked and placed into the blister packs by workers then the top film of each blister pack is heat-sealed.In making leukocyte reduction filters, filter membranes are punched, overlayed, and put in filter housings.These leucocyte reduction filters are then assembled into the products in the above-mentioned manufacturing process.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates of filter membranes.The membranes that have conformed to the standards are used in the assembling process.We reviewed the manufacturing process and the record of filter membrane manufacture.There were no equipment trouble/problems and we confirmed that the filter membranes conformed to all standards.Release testing, which includes measurements of solution concentration and volume and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the production number and confirmed that there were no anomalies in all release testing items.The product conformed to the standards.Regarding the retained sample of the lot number concerned, three sets were visually inspected.There were not any occlusions in tubing, blocking, or any abnormalities in their appearances.Root cause: no abnormalities were observed in the manufacturing record of the lot number concerned and it was confirmed that the lot manufactured as per usual.In the above-mentioned investigations of the set returned, normal saline flowed slowly through the filter, and the first through third filter membranes from the inlet side were dyed darker with toluidine blue; therefore, occlusion may have occurred in the filter media.When the filter media occluded, blood may have been filtered by the filter area which was smaller than usual, thus pressure was applied to the filter media and consequently leukocyte leakage was likely to occur.Leukoreduction failure is commonly caused by the following factors: 1) analysis affected by blood properties of donors the following blood properties or blood conditions on blood collection may cause wbc count failures.For the details, please refer to the excerpt from the literature.Spurious counts and spurious results on wbc counts (spurious increase) platelet aggregates / large platelets nucleated red blood cells rbc resistant to lysis immunoglobulin lipids microorganisms / bacterial aggregates zandecki m, genevieve f, gerard j, godon a.Spurious counts and spurious results on haematology analyzers: a review.Part ii: white blood cells, red blood cells, hemoglobin, red cell indices and reticulocytes.International journal of laboratory hematology.2007, 29, 2141, table 1.2) pressure loaded on filter membranes where a physical stress on filter membranes is greater than what is expected, trapped white blood cells are pushed out of the filter membranes and may result in leukoreduction failure.For the prevention of leukoreduction failure, the instructions for use (ifu) of the product state: "[caution] do not squeeze or apply pressure on the filter while it is attached to the bag containing the filtered blood".

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya CO ; JA
• Manufacturer (Section G): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP; 818 misonodaira; fujinomiya 418-0 004; JA 418-0004
• Manufacturer Contact: makoto yoshikawa ; 818 misonodaira; fujinomiya 418-0-004 ; JA 418-0004
• MDR Report Key: 18667974
• MDR Text Key: 334901654
• Report Number: 9681839-2024-00004
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 230601AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2024
• Date Manufacturer Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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