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

Catalog Number 1BBLGQ506A6

Device Problems Defective Component (2292); High Test Results (2457)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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)(4).

Manufacturer Narrative

This report is being filed to provide additional information: investigation: one set of blood bags with the filter from the collection set were returnedfor evaluation.The white clamp above the filter was closed and 570ml of water was injected into thedonation bag to check if water would pass though the one-way valve line the bypass linethrough natural dropping.It was confirmed that the water did not flow pass the one-way valveand air did not pass through the lower side from the upper side.It was confirmed that theone-way valve was normal.The leukoreduction filter was tested for flow rate and air leaks.A slow flow rate of 12.5 ml/inwas noted and it was confirmed the filter was connected in the correct direction and noanomalies were observed in the line.The manufacturing records, test records, and inspection records were reviewed forabnormalities and none were found.There were no equipment issues at the time ofmanufacture that would have contributed to the reported event.It was confirmed that there were no similar complaints from other medical institutions for thereported event as of 07/06/2018.The records regarding the particulate removal rates of the filter membranes were reviewed.Allmembranes conformed to established specification.Root cause: a definitive root cause for the observed elevated wbc count remainsundetermined at this time.The returned sample was almost entirely dyed darker with toluidineblue, therefore, it is possible that occlusion occurred in the second filter membrane andsubsequent filter membranes.Hence, blood may have been filtered by a smaller than usual filterarea and the linear speed increased and resulted in leukocyte contamination.For this event, the extension of filtration time is likely to occur concurrently.For previouslyreported similar events, the clogged components were inferred to be aggregate platelets.It ispossible that the platelets which were activated and aggregated were trapped by the filter.Asa result, a clogged filter may have occurred and interrupted blood flow.

• 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: 7666002
• MDR Text Key: 113642364
• Report Number: 9681839-2018-00045
• 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: 07/06/2018

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: 11/30/2018
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 170630AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/13/2018
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2018
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/06/2018
• Supplement Dates Manufacturer Received: 07/10/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other