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

Catalog Number 1BBWGQ506A2

Device Problems High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 04/05/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.There was not a transfusion recipient or patient involved at the time of whole blood processing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6) terumo bct is awaiting return of the disposable set.

Manufacturer Narrative

This report is being filed to provide additional information in h.3, h.6 and h.10.Investigation: we received the collection bag with the leukocyte reduction filter returned from the customer.We discharged the blood remained inside the collection bag on a testing sieve (mesh size: 90 m, mesh: no.170) and rinsed it with water then visually inspected whether there were any residues on the sieve.We did not observe blood clots or other foreign matters that could cause filter blockage.We cut the tubing connected to the outlet of the leukocyte reduction filter assembly to visually inspect whether there were any residues, as with 2).We did not observe blood clots and so forth.We cut the tubing connected to the inlet of the leukocyte reduction filter assembly to connect to a soft bag containing normal saline, and let normal saline flow by gravity for rinsing.We then let normal saline flow again and confirmed that it flowed through without problem.In order to confirm that there was no problem with the airtightness of the filter portion, the tab sheet covering the outflow side of the filter was cut out to expose the filter media, and air was injected into the filter, which was submerged in water, from its inlet at a gauge pressure of 0.4 mpa.It was confirmed that no abnormal air leakage occurred.In regard to the filter media (i.E.Six pieces) contained in the leukocyte reduction filter assembly, we took out the filter media one by one from the front side of the filter and set them in a row on a waste cloth for further observation.We did not observe the adhesion of residues which were presumed to be blood clots.We also confirmed that all the filter media facing the correct direction were placed in the filter assembly.In order to examine the state of trapped white blood cells in the filter media, we stained all the filter media with toluidine blue* to see the state of staining.It was confirmed that all the filter medial were locally stained dark blue although they differed in degree.In regard to the filter media used for the leukocyte reduction filter assembly of the product in question, the filter media is formed as the primary membrane by processing non-woven fabric (base material of the filter) in the primary membrane making process.Then, the primary membrane is further processed to make three types of the secondary membranes: hn type, hc type, and hsp type.For hn type, the primary membrane is processed through the slicing process, cleaning process, and hydrophilic treatment process.This type intends to mainly remove white blood cells.For hc type and hsp type, the primary membrane is processed through the above-mentioned processes and further processed by cationization treatment.These types intend to remove not only white blood cells but also platelets more effectively by cationization treatment.Therefore, the filter media consists of two each of these three secondary membranes, that is, there are six secondary membranes in total.The leukocyte reduction filter assembly is made by stacking and cutting these six membranes followed by the soft shell assembling process.Regarding leukoreduction performance of the filter, the following in-process control tests are performed.Nh type: tests of particulate removal rates and hydrophilicity levels hc type and hsp type: tests of particulate removal rates, hydrophilicity levels, and cationization levels leukoreduction performance is assessed by confirming that these test results conformed to the test specifications.We reviewed the test results of these types of the secondary filter membranes used for the product in question and confirmed that all the test standards were satisfied.We also reviewed the record of the manufacturing process (the membrane making process through the soft shell assembling process) of the leukocyte reduction filter assembly and did not observe any abnormalities or deviations that could affect product quality.For release testing of the product concerned, the blood preservative solution (cpd solution) was tested on quantitative tests of sodium citrate hydrate, citric acid hydrate, dextrose, and sodium dihydrogen phosphate, and on net volume measurement and they were satisfied.We reviewed the testing and inspection record of the reported lot number and confirmed that the results of the tests mentioned above conformed to the standards.We have not received any complaints about wbc count failures associated with the same lot number.Root cause: based on the analysis of the returned set mentioned in the preceding section, it was confirmed that all the filter media were stained intensely dark blue locally by staining with toluidine blue.Hence it was inferred that the inflow of non-uniform blood occurred for part of the filter for some reason.In this case, it is presumed that blood is likely to be filtered faster than usual.We did not observe any abnormalities or deviations in the investigation of the records; therefore, we believe that the leukocyte reduction filter used this time conformed to our quality standards.From the above, it was inferred from the confirmation of the state of staining the filter of the returned set that uneven inflow of blood occurred in the filter which was different from normal; however, we were not able to identify the cause of the occurrence of the wbc count failure in question.Furthermore, from the investigation results and so forth of the past similar issues which our factory received, the following cases are cited as common causes of wbc count failures: - blood characteristics of a donor; and - white blood cells are leaked from the filter due to applying pressure to the collection bag or filter during filtering the collected blood.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya ; JA
• MDR Report Key: 11770118
• MDR Text Key: 280750982
• Report Number: 9681839-2021-00006
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

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 Expiration Date: 03/31/2023
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 201021AF
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 04/13/2021
• Initial Date FDA Received: 05/04/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other