MAUDE Adverse Event Report: TERUMO BCT 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 12/16/2022

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 product.Donor unit #: (b)(6) 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.Terumo bct is awaiting the return of the set.

Manufacturer Narrative

Investigation: the set concerned has not yet been provided for evaluation.We therefore conducted investigations 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 leukoreduction 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.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.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the 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 no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Root cause: we reviewed the manufacturing record and the testing and inspection record of the lot number concerned; however, we did not find any abnormalities and we were not able to identify the cause of the issue.Leukoreduction failure is commonly caused by the following factors: blood characteristics of donors there is a possibility of leukoreduction failure due to blood characteristics of donor or pressure loaded on filter membranes for some reason, 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¿.We confirmed in some complaints previously reported that the following cases caused leukoreduction failure.- blood was filtered within 30 minutes after blood collection.- the tube below the filter was not clamped before blood flowed into the filter when expelling air.

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 product.Donor unit #: (b)(6).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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in h.10.Corrected investigation: we received the set returned from the customer for evaluation.We received the collection bag with the leukocyte reduction filter.The filter was rinsed with normal saline.The flow rate of normal saline was 12 ml/min, which was slow.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.An air 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.I) the tab sheet covering the outflow side (second side) of the filter is cut out carefully and exposed the outflow side to allow observing the frame sheet (partition) directly.Ii) air is admitted to the filter from the inflow-side tube at a gauge pressure of 39.2 kpa (0.4 kgf/cm2) for approximately 10 seconds in order to check whether there is any air leakage from the frame sheet (partition).After passing normal saline through the filter, we dyed the filter media with toluidine blue for observation.We noticed that the fourth through sixth filter media were dyed dark, that is, white blood cells were accumulated in these dyed areas.Investigation: 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 leukoreduction 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.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.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the 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 no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Corrected root cause: we did not observe any abnormalities in the filter returned from the customer.We noticed that the fourth through sixth filter media were dyed dark with toluidine blue.Therefore, occlusion may have occurred, and blood may have been filtered by the filter area that was smaller than usual, and the linear speed (flow rate per unit area) increased, and then the leukoreduction failures (elevated wbc counts) occurred.

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 product.Corrected donor unit #: (b)(6) 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.

Manufacturer Narrative

This report is being filed to provide corrected information in b.5 corrected investigation: we received the set returned from the customer for evaluation.We received the collection bag with the leukocyte reduction filter.The filter was rinsed with normal saline.The flow rate of normal saline was 12 ml/min, which was slow.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.An air 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.I) the tab sheet covering the outflow side (second side) of the filter is cut out carefully and exposed the outflow side to allow observing the frame sheet (partition) directly.Ii) air is admitted to the filter from the inflow-side tube at a gauge pressure of 39.2 kpa (0.4 kgf/cm2) for approximately 10 seconds in order to check whether there is any air leakage from the frame sheet (partition).After passing normal saline through the filter, we dyed the filter media with toluidine blue for observation.We noticed that the fourth through sixth filter media were dyed dark, that is, white blood cells were accumulated in these dyed areas.Investigation: 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 leukoreduction 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.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.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the 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 no abnormalities in their appearances.We used one of the sets to measure the solution volume and used another one of the sets to perform a quantitative test for the composition of the solution in the same manner as the release testing.The measured results conformed to our in-house standards.Corrected root cause: we did not observe any abnormalities in the filter returned from the customer.We noticed that the fourth through sixth filter media were dyed dark with toluidine blue.Therefore, occlusion may have occurred, and blood may have been filtered by the filter area that was smaller than usual, and the linear speed (flow rate per unit area) increased, and then the leukoreduction failures (elevated wbc counts) occurred.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• 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: 16147560
• MDR Text Key: 308944421
• Report Number: 9681839-2023-00003
• 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,Followup
• Report Date: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 220525AG
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2022
• Initial Date FDA Received: 01/12/2023
• Supplement Dates Manufacturer Received: 01/30/2023; 04/18/2023
• Supplement Dates FDA Received: 02/06/2023; 04/20/2023
• 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