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

Catalog Number 1BBWGQ506A2

Device Problems Restricted Flow rate (1248); High Test Results (2457); Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 02/18/2020

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).

Manufacturer Narrative

This report is being filed to provide additional information in h.3, h.6 and h.10.Investigation: one filter from the collection set was returned for evaluation.The leukoreduction filter was tested for flow rate and air leaks.A slow flow rate of 6ml/min was noted, and it was confirmed there were no air leaks.The filter was disassembled to observe the appearance of filter membranes and noticed creases in the filter membranes of the filter.The creases in the filter were not different from those in conforming products and in the filter membranes and aggregation was observed in the first and second filter membranes.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.All membranes conformed to established specification.Shipping testing was performed on the reserve samples from the reported lot number.The reserve samples were also visually examined, and the solution volume and solution composition were tested with no abnormalities noted.All product conformed to the established specification.Root cause: control to maintain cationization levels above a certain level during the production of filter membranes in order to prevent from leukocyte leakage.Where a cationization level is high, filtration rate is likely to be low.For the prevention of leukocyte leakage, the instructions for use of the product state: "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".The above-mentioned investigation results revealed that there were no abnormalities in the manufacturing record and the testing and inspection record of the reported lot number.The returned filter also revealed no abnormalities in themselves.It was noticed that all the filter membranes were locally dyed dark with toluidine blue.Therefore, occlusion may have occurred and blood may have been filtered by the filter area which was smaller than usual and the linear speed (flow rate per unit area) increased, and then leukocyte leakage occurred.There was observed aggregation in the first and second filter membranes from the inflow side of the filter.Therefore it is inferred that excessive aggregates in the donation bag flowed into the filter after the start of filtration and caused clogging in the inflow side of the filter layers.There is also a possibility that the blood may have been separated in the donation bag and the separated blood did not disappear even after being agitated prior to filtration.As a result, the blood with high flow resistance flowed into the filter and occluded the inflow side of the filter layers; therefore, leukocyte leakage may have occurred by the increase in the linear speed due to occlusion in the areas with aggregation.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya
• MDR Report Key: 9827479
• MDR Text Key: 185767667
• Report Number: 9681839-2020-00016
• 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: 03/12/2020

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: 12/31/2021
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 190718AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/18/2020
• Initial Date FDA Received: 03/12/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other