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

Catalog Number 1BBLGQ506A6

Device Problems Restricted Flow rate (1248); Defective Component (2292); Defective Device (2588); Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 07/31/2019

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.6 and h.10.Corrected information is provided in h.3.Investigation: one filter from the collection set was returned for evaluation.The leukoreduction filter was tested for flow rate.A slow flow rate of 5ml/min was observed.The returned sample revealed that the filter was connected in the right direction and no anomalies such as clogging and kink were observed in the line.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.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.All standards were met for the reported production number for the volume measurement of blood preservative solution and the quantitative test for the composition of the solution.Root cause: based on the available information,it was found that normal saline flowed through the filter slowly and all the filter membranes of the filter were locally dyed dark with toluidine blue; therefore, occlusion may have occurred in the filter.The investigation showed residual blood was locally observed in all filter membranes and inferring that occlusion had locally occurred.Hence, 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 consequently leukocyte leakage may have occurred.In this case specifically, the extension of filtration time is likely to occur concurrently.On the basis of the previously reported similar incidents, it was inferred that the clogged components were the aggregated platelets that were activated and aggregated for some reason and got trapped by the filter.Correction:in order to reduce the risk of formation of blood aggregation,it is recommended that donation bag was inverted several times immediately after blood collection to ensure that blood and anticoagulant became well-mixed and the bag should be fully agitated before the start of filtration for the even disperse of the separated blood components.

Manufacturer Narrative

This report is being filed to provide additional information in d.10.Investigation is in process.A follow up report will be provided.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya
• MDR Report Key: 8950053
• MDR Text Key: 241261409
• Report Number: 9681839-2019-00054
• 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,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 181025AG
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other