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); Defective Component (2292); High Test Results (2457); Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 09/05/2019

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 in e.3, h.3, h.6 and h.10.Investigation: one set of blood bags with the filter from the collection set was returned forevaluation.The leukoreduction filter was tested for flow rate and air leaks.A slow flow rate of 3ml/minwas noted, and it was confirmed there were no air leaks.The filter was disassembled to observe the appearance of filter membranes and noticed creasesin the filter membranes of the filter.The creases in the filter were not different from those inconforming products and in the filter membranes aggregation was observed in the firstthrough fifth filter membranes.The manufacturing records, test records, and inspection records were reviewed forabnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.Allmembranes conformed to established specification.Shipping testing was performed on the reserve samples from the reported lot number.Thereserve samples were also visually examined, and the solution volume and solution compositionwere tested with no abnormalities noted.All product conformed to the establishedspecification.Root cause: based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the whole blood product could be due to an occlusion, we noticedthat the fsecond through fifth filter membranes from the inflow side of thefilter were locally dyed dark with toluidine blue.The investigation showed aggregation on any of the first through fifthmembranes.Therefore, occlusion may have occurred, andblood may have been filtered by the filter area which was smaller than usual and the linearspeed (flow rate per unit area) increased, and then leukocyte leakage occurred.In the filtermembranes of w010719002028, we observed aggregation in the first through fifthmembranes.We therefore infer that excessive aggregates in the donation bag flowed into thefilter after the start of filtration and caused clogging on the inflow side of the filter layers.There is also a possibility that the blood may have been separated in the donation bag and theseparated blood did not disappear even after being agitated prior to filtration.As a result, theblood with high flow resistance flowed into the filter and occluded the inflow side of the filterlayers; therefore, leukocyte leakage may have occurred by the increase in the linear speed dueto occlusion in the areas with aggregation.In regard to blocking by aggregates, the following is recommended:-reducing the risk of forming blood aggregation.Please invert the donation bag several timesimmediately after blood collection to ensure that blood and anticoagulant are well-mixed, and-reducing the risk of slow blood flow by fully agitating the donation bag before the start offiltration to evenly disperse the separated blood components.

• 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: 9166714
• MDR Text Key: 182739994
• Report Number: 9681839-2019-00057
• 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: 10/08/2019

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: 10/17/2019
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 181024AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2019
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/13/2019
• Initial Date FDA Received: 10/08/2019
• Supplement Dates Manufacturer Received: 10/29/2019
• Supplement Dates FDA Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other