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); High Test Results (2457); Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 09/27/2019

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).

Manufacturer Narrative

This report is being filed to provide additional information.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 noted.The filter was disassembled to confirmed that anomalies such as detached or misaligned membranes were not observed in the filter.The number of filter membranes used for the filter conformed to the specification.We also observe the appearance of filter membranes.Residual blood, which had not been rinsed, was locally observed in all filter membranes.It was confirmed 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.It was confirmed that no similar complaints were reported from any other customers against the reported lot number as of october 31, 2019.Root cause: with regard to the returned sample, normal saline flowed through the filter slowly and the second filter membrane from the inflow side (i.E.The first one of the main membranes with minute pores) of the filter was entirely dyed dark with toluidine blue; therefore, occlusion may have occurred in the filter.Residual blood was locally observed in all filter membranes and we inferred 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 occurred.In this case, the extension of filtration time is likely to occur concurrently.From the previously-reported similar incidents, it was inferred the clogged components were aggregated platelets.It is deemed that platelets, which were activated and aggregated for some reason, were trapped by the filter.In regard to occlusion by blood aggregates, it is recommended to fully agitate the donation bag after collection in order to reduce the risk of formation of aggregation.In addition, to reduce the risk of slow blood flow, the bag should be fully agitated before the start of filtration to evenly disperse the separated blood components.

• 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: 9239520
• MDR Text Key: 182543952
• Report Number: 9681839-2019-00069
• 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: 10/25/2019

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: 08/31/2020
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 190313AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other