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

Catalog Number 1BBWGQ506A2

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 02/14/2023

Event Type  malfunction  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

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.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.The wbc count is not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the set in question was not returned for investigation and we therefore conducted the following investigations based on the information provided.Concerning 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.Lot number(s) is not specified, and we reviewed the manufacturing records of the lot numbers over the past three years.In the assembling process and the filter assembling process, the records revealed no abnormalities that would lead to the issue.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 the testing and inspection records of the lot numbers over the past three years, and no abnormalities were observed.Root cause: as stated in the investigation results above, we did not see any abnormalities in the relevant records over the past three years; therefore, we were not able to identify the cause of the issue.Leukoreduction failure is commonly caused by the following factors: 1) blood characteristics of donors there is a possibility of leukoreduction failure due to blood characteristics of donors such as sickle cell trait and cold agglutinin.Leukoreduction failure resulting from blood characteristics is reported in several literatures as follows and it would be appreciated if you could refer to these reports.· int.Jnl.Lab.Hem., 2007(1), 29, 4¿20.· int.Jnl.Lab.Hem., 2007(1), 29, 21¿41.· ann lab med., 2018, 38(4), 371¿374.· transfusion, 2022, 62(9), 1727¿1730.2) 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 past complaints 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.Concerning occlusion during filtration, there are two major factors: "occlusion in the tubing" and "occlusion in the filter".The following cases are possible causes of occlusion.1) clicktip is not fully broken if the cliktip is not fully broken, a hole inside is partially made and enough blood volume cannot be obtained.It is recommended to break the cliktip firmly by snapping in both directions (back and forth) in order to break the cliktip completely.2) cliktip gets into the joint of the donor tube in the upper part of the cover tube when breaking the cliktip after breaking the cliktip, rub (or pinch) the joint of the tubing with the fingers in order to prevent the cliktip from getting in the upper part of the cover tube.In this way, users can perform filtration smoothly.3) insufficient mixing of blood in unfiltered bag before filtration if the bag stands still between the time of blood collection and filtration, red blood cells in the bag settle out and are concentrated.The concentrated portion of red blood cells increases viscosity and possibly causes occlusion if the blood is filtered as it is.4) occlusion of clots in filter membranes if microaggregates are formed in the bag before filtration for some reason, the aggregates cause occlusion in the filter membranes and obstruct the flow.Citations: zandecki, m., genevieve, f., gerard, j., & godon, a.(2007).Spurious counts and spurious results on haematology analysers: a review.Part i: platelets.Clinical and laboratory haematology, 29(1), 4-20.Https://doi.Org/10.1111/j.1365-2257.2006.00870.X gehrie ea, petran l, young pp.Sickle cell trait results in a high leukoreduction quality control failure rate for whole blood donations.Transfusion.2022;62(9): 1727¿30.Https://doi.Org/10.1111/trf.17021 rim jh, chang mh, oh j, gee hy, kim jh, yoo j.Effects of cold agglutinin on the accuracy of complete blood count results and optimal sample pretreatment protocols for eliminating such effects.Ann lab med.2018 jul;38(4):371-374.Doi: 10.3343/alm.2018.38.4.371.Pmid: (b)(6); pmcid: (b)(6).Zandecki, m., genevieve, f., gerard, j., & godon, a.(2007).Spurious counts and spurious results on haematology analysers: a review.Part ii: white blood cells, red blood cells, haemoglobin, red cell indices and reticulocytes.Clinical and laboratory haematology, 29(1), 21-41.Https://doi.Org/10.1111/j.1365-2257.2006.00871.X.

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.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.The wbc count is not available at this time.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP 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: 16522028
• MDR Text Key: 311581191
• Report Number: 9681839-2023-00013
• 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: 03/10/2023

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: No
• 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