MAUDE Adverse Event Report: TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORPORATION IMUFLEX BLOOD BAG SYSTEM; IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER

Catalog Number 1BBWGQ506A2

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

Patient Problem Hemolysis (1886)

Event Date 02/08/2024

Event Type  malfunction  

Event Description

The customer reported that during product processing the plasma unit took longer than normal to perform leukoreduction using an imuflex blood bag system.Per the customer, the plasma unit rested for greater than 60 minutes and was leukoreduced at room temperature.The "delayed" leukoreduction has resulted in hemolyzed plasma.Unit# (b)(6) per the customer no red blood cells were observed in the plasma units while resting and there were no clots visible in the channel or channel lines.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 set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the set concerned was not returned for investigation.We therefore conducted investigation based on the information provided.In regard to the product concerned, sealed bags are filled with solution and the line is assembled.These bags are sterilized, stacked, and placed into the blister packs.The top film of each blister pack is heat-sealed.For the leukocyte reduction filter, filter membranes are punched out, laminated, and integrated into soft housing.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates and cationization levels of each filter membrane.The standards of average cationization levels of laminated filter membranes have also been set and controlled.We reviewed the manufacturing record of the lot number in question and confirmed that no abnormalities occurred in any processes, and production was run in the usual manner.We reviewed the testing and inspection record of the lot number in question and confirmed that no abnormalities were detected in the volume measurement of blood preservative solution and the quantitative test for the composition of the solution.All standards were satisfied.Regarding the retained sample of the lot number concerned, three sets were visually inspected.There were not any occlusions in tubing, blocking, or any abnormalities in their appearances.Root cause: as the above-mentioned investigation results, the manufacturing record and the testing and inspection record of the lot number in question revealed no abnormalities; therefore, it was confirmed that the production was run in the usual manner.Regarding the occurrence of hemolysis observed in the product concerned, we infer that it may have been caused by ¿pressure loading on filter media¿.However, we were not able to identify the specific cause of the event.It is recommended to invert the blood bag thoroughly before filtration.If you observe any abnormalities in the filtered blood such as color tone, it would be recommended to discontinue using the product.If the extended filtration time is frequently observed, it is recommended to rest the unit for two hours after the collection to inhibit platelet activation and it is inferred that this process leads to the inhibition of occlusion results during filtration.It would be recommended resting the unit after collection and invert the unit for fully mixing before filtration.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORPORATION; fujinomiya 418-0 004; JA 418-0004
• Manufacturer (Section G): TERUMO CORPORATION, FUJINOMIYA FACTORY OF TERUMO CORPORATION; 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: 18870821
• MDR Text Key: 337267688
• Report Number: 9681839-2024-00008
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 230829AF
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/13/2024
• 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