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

Catalog Number 1BBLGQ506A6

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 01/15/2023

Event Type  malfunction  

Manufacturer Narrative

Investigation: the set concerned was not available 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 the sealed bags with a leukocyte reduction filter.The valve assembly is purchased from the supplier.We reviewed the manufacturing record of the lot number in question to check if there were any abnormalities or deviations relating to the issue.No abnormalities or deviations were observed.Release testing, including a visual inspection and other items, is performed on the product concerned on a sample basis.We reviewed each testing and inspection record of the lot number in question and confirmed that there were no anomalies in all testing items.The product conformed to the standards.We used three sets of the retention sample of the lot number in question to perform filtration with colored normal saline in order 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 associated with the lot number in question were reported by other customers.It was confirmed that any similar complaints were not reported by other customers as of february 20, 2023.Root cause: we did not see any abnormalities in the manufacturing record or the testing and inspection record, and we were not able to identify the cause of the issue.The set in question was not available for investigation.

Event Description

The customer an elevated white blood cell (wbc) content in the whole blood product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.Donor unit id: (b)(6) the collection set is not available for return because it was discarded by the customer.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya 418-0 004; JA 418-0004
• Manufacturer (Section G): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP; 818 misonodaira; fujinomiya 418-0 004; JA 418-0004
• Manufacturer Contact: makoto yoshikawa ; 818 misonodaira; fujinomiya 418-0-004 ; JA 418-0004
• MDR Report Key: 16438632
• MDR Text Key: 310383009
• Report Number: 9681839-2023-00011
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/24/2023

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: 10/31/2023
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 220520AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2023
• Initial Date FDA Received: 02/24/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other