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); High Test Results (2457)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

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).The collection set is not available for return because it was discarded by the customer.The wbc count is not available, at this time.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: the set was unavailable for investigation and we therefore conducted the following investigations based on the information provided.Upon making the blood bag concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister trays.The top film of each blister tray is heat-sealed.The bypass line is assembled by connecting a tube to one end of a valve assembly then performing one-hundred percent leak test and connecting a tube to the other end of the valve assembly.During the entire line assembly prior to sterilization, the bypass line is jointed to sealed bags with a leukoreduction filter.The valve assembly is purchased from the supplier.We reviewed the manufacturing record of the reported lot number to check if there were any abnormalities or deviations relating to the issue.No abnormalities or deviations were observed.Shipping testing, including the measurement of solution concentration and volume, and a visual inspection, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the reported lot number and confirmed that there were no anomalies in all shipping testing items.The product conformed to the standards.We used three sets of the retention sample of the reported lot number to perform filtration with water to check whether the water passes through the one-way valve.We confirmed that the water did not pass beyond the valve in each sample.We investigated whether any complaints against the reported lot number had been reported by other customers.No report regarding leukocyte leakage was made by other customers as of november 9, 2020.Root cause: the results of the investigation of related records revealed no abnormalities and we were not able to identify the cause of the issue.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya ; JA
• MDR Report Key: 10848307
• MDR Text Key: 219341142
• Report Number: 9681839-2020-00101
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

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: 05/31/2021
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 191219AG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 10/23/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 11/12/2020
• Supplement Dates FDA Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other