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 04/05/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the set concerned was not returned 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.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.We visually inspected three sets of our retained samples of the lot number concerned.There were no abnormalities, such as tubing occlusion and blockage, in their appearances.We also used the samples to measure the solution volume and 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.No abnormalities were observed.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.Wbc contamination is commonly caused by the following factors: 1) blood characteristics of donors there is a possibility of wbc contamination due to blood characteristics of donors.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 contamination.For the prevention of wbc contamination, 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 contamination.- 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 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 residual wbc testing, 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.

• 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 ; JA
• 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: 16865521
• MDR Text Key: 314886302
• Report Number: 9681839-2023-00031
• 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
• Report Date: 05/03/2023

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: 220720AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2023
• Initial Date FDA Received: 05/03/2023
• 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