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 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the set concerned was not available and we therefore conducted the following investigations based on the information provided.Upon making the blood bag concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray 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.Review of the manufacturing record of the lot number in question was performed.It was confirmed that no abnormalities occurred in any process, and the products were manufactured as usual.Release testing, including a visual inspection and other items, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the lot number in question and confirmed that there were no anomalies in all testing items.The product conformed to the standards.Three sets of retained samples of the lot number concerned were visually inspected.There were no abnormalities, such as tubing occlusion and blockage, in their appearances.Root cause: review of the manufacturing record and the testing and inspection record of the lot number concerned was performed; however, we did not find any abnormalities and we were not able to identify the cause of the issue.Wbc count failure is commonly caused by the following factors: 1) blood characteristics of donors there is a possibility of wbc count failure due to blood characteristics of donors such as hemolysis, sickle cell trait, and cold agglutinin.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 wbc count failure.For the prevention of wbc count 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 wbc count 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.The platelet collection set is not available for return because it was discarded by the customer.

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.The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the set concerned was not available and we therefore conducted the following investigations based on the information provided.Upon making the blood bag concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray 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.Review of the manufacturing record of the lot number in question was performed.It was confirmed that no abnormalities occurred in any process, and the products were manufactured as usual.Release testing, including a visual inspection and other items, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the lot number in question and confirmed that there were no anomalies in all testing items.The product conformed to the standards.Three sets of retained samples of the lot number concerned were visually inspected.There were no abnormalities, such as tubing occlusion and blockage, in their appearances.Root cause: review of the manufacturing record and the testing and inspection record of the lot number concerned was performed; however, we did not find any abnormalities and we were not able to identify the cause of the issue.Wbc count failure is commonly caused by the following factors: blood characteristics of donors there is a possibility of wbc count failure due to blood characteristics of donors such as hemolysis, sickle cell trait, and cold agglutinin.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 wbc count failure.For the prevention of wbc count 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 wbc count 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.

• 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: 16646304
• MDR Text Key: 312887708
• Report Number: 9681839-2023-00020
• 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: 03/30/2023

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: 220913AG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2023
• Initial Date FDA Received: 03/30/2023
• Supplement Dates Manufacturer Received: 04/19/2023
• Supplement Dates FDA Received: 04/24/2023
• 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