MAUDE Adverse Event Report: TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP 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 03/17/2024

Event Type  malfunction  

Event Description

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

Manufacturer Narrative

Investigation: the set concerned was not available for investigation and we conducted the following investigations based on the information provided.In making the blood bags concerned, with the use of automated equipment, sealed bags are filled with solution and the line is assembled, then sterilized.The workers stack the bags and place them into the blister packs.The top film of each blister pack is heat-sealed.The bypass line of the product concerned is assembled by the supplier.The one-way valve used in the bypass line is tested for aeration and leakage on the entire valve quantity prior to tubing connection, and the one-way valves that have passed the tests are assembled in the bypass lines.In our manufacturing process, the bypass line assembled is connected to the filter then to the welded bags.Regarding the one-way valves used in the product lot concerned (two one-way valve lots, that is, 30905 pieces in total), we reviewed the test records for appearance, aeration, and leakage, and it was confirmed that there were no abnormalities such as multiple occurrences of defects.Release testing, including appearance inspection, is performed on the product concerned on a sample basis.We reviewed the testing and inspection record of the lot number in question and confirmed that there were no abnormalities in all testing items.The product conformed to the specifications.We used three sets of the retention sample of the product lot number concerned to check the rubber valve inside the one-way valve.We did not observe any differences from conforming products.With regard to the product lot number concerned, we confirmed that we had not received similar complaints (including blood backflow and blood passing beyond the one-way valve) from any other customers as of april 11, 2024.Root cause: as the above-mentioned investigation results, any abnormalities were observed in the manufacturing record and the testing and inspection record of the product concerned, including the supplier; therefore, we were not able to identify the cause of the occurrence of this event.Regarding the one-way valve used in the product concerned, blood may flow through the valve when a high pressure or load is applied to.It would be appreciated if you could pay attention to avoid applying pressure to the collection bag during filtration.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORP; 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: 19195684
• MDR Text Key: 341802720
• Report Number: 9681839-2024-00013
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 230609AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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