MAUDE Adverse Event Report: TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER

Catalog Number 1BBWGQ506A2

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

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

Event Date 07/06/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: we have not received the sets returned from the customer.We therefore performed investigation based on the provided information.In regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.For the leukocyte reduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.Only the filter media that have passed the standards are incorporated into the housing.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.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.We also measured the volume and concentration of the solution in the same manner as the release testing.We did not see any abnormalities, and the results conformed to our in-house standards.Root cause:as mentioned above, no abnormalities were observed in the manufacturing process or retained samples, and we were not able to identify the cause of the issue.Leukoreduction failures are 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", and ¿clamp the blood filled tubing before blood enters the filter¿.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.Donor unit #: (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.The collection set is not available for return because it was discarded by the customer.

Event Description

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

This report is being filed to provide additional information in h.3, h.6 and h.10.Investigation: we examined the sets concerned, which we received.In regard to the production of imuflex, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.For the leukocyte reduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.Only the filter media that have passed the standards are incorporated into the housing.We reviewed the manufacturing record of the lot number in question and confirmed that no anomalies occurred in any process, and the products were manufactured as usual.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.We also measured the volume and concentration of the solution in the same manner as the release testing.We did not see any abnormalities, and the results conformed to our in-house standards.The filter of the set was rinsed with normal saline.We were not able to measure a flow rate as blockage occurred in the filter.An airtightness test (i.E.Leak test) was performed on the filter in accordance with the following procedures and we confirmed that air leaks were not observed in any locations of the filter.We disassembled the rinsed filter to observe the appearance of filter media (membranes).We noticed creases in the filter media; however, the creases were not different from those observed in conforming products.We did not observe aggregates adhered to the filter media we dyed the filter media with toluidine blue for observation.We noticed that the second through fourth filter membranes from the inlet side of the filter were dyed dark, that is, white blood cells were accumulated in these dark dyed areas.We also observed dark dyed areas in the first filter membrane from the inlet side of the filter due to minute aggregates.Corrected root cause: no abnormalities were observed in the manufacturing record or the testing and inspection record of the lot number concerned.We also investigated the retained samples of the lot number concerned, and the results revealed no abnormalities.Regarding the filters of the sets returned, the filter media in each filter were dyed dark, and the first filter membrane from the inlet side of each filter was dyed dark due to minute aggregates; therefore, occlusion caused by the aggregation of white blood cells or platelets may have occurred.Blood may have been filtered by the filter area which was smaller than usual, and the linear speed (flow rate per unit area) increased and consequently leukocyte leakage occurred.In addition, we observed in the filter of (b)(6) that blood adhered to the whole filter media.Hence the filter pores may have been blocked due to the blood properties of the donor, or lipids may have caused wbc count failure due to lipids during the blood cell count.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP; fujinomiya 418-0 004; JA 418-0004
• 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: 17453552
• MDR Text Key: 321434182
• Report Number: 9681839-2023-00046
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/03/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 220921AF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 08/03/2023
• Supplement Dates Manufacturer Received: 08/07/2023
• Supplement Dates FDA Received: 08/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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