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 03/25/2024

Event Type  malfunction  

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 the residual wbc testing, 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: we received the information stated in ¿complaint¿ above with a picture although the set concerned was not available for investigation.In the picture, we confirmed that blood filled the filter and flowed into the bypass line.We conducted the following investigations in light of the information and the picture 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.(1) filter assembly in making the leukocyte reduction filter, filter membranes are punched, overlayed, and put in the filter housing.The leucocyte reduction filter is then assembled into the product in the above-mentioned manufacturing process.In order to ensure leukoreduction performance and to prevent filter occlusion in and hemolysis, standards have been set to control particulate removal rates of filter membranes.The membranes that have conformed to the standards are used in the assembling process.We investigated the manufacturing process and the manufacturing record of filter media.No abnormalities such as equipment trouble were observed and we confirmed that the filter media conformed to all the specifications.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, 17982 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 perform the appearance inspection.There were no abnormalities such as kinks or occlusion in the tubing.In addition, we checked the rubber valve inside the one-way valve and 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 extended filtration time, incomplete filtration, blood backflow, and blood passing beyond the one-way valve) from any other customers as of april 8, 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.There are two major factors of occlusion during filtration: "occlusion in the tubing" and "occlusion in the filter".The following cases are possible causes of occlusion.1) clicktip is not fully broken if the cliktip is not fully broken, a hole inside is partially made and enough blood volume cannot be obtained.It is recommended to break the cliktip firmly by snapping in both directions (back and forth) in order to break the cliktip completely.2) cliktip gets into the joint of the donor tube in the upper part of the cover tube when breaking the cliktip if the cliktip gets into the joint of the donor tube in the upper part of the cover tube after breaking, it may block the flow path.To ensure an adequate flow path of blood, rub (or pinch) the joint of the tubing with the fingers in order to prevent the cliktip from getting in the upper part of the cover tube.3) insufficient mixing of blood in unfiltered bag before filtration if the bag stands still between the time of blood collection and filtration, red blood cells in the bag settle out and are concentrated.The concentrated portion of red blood cells increases viscosity and possibly causes occlusion if the blood is filtered as it is.4) occlusion of clots in filter membranes if microaggregates are formed in the bag before filtration for some reason, the aggregates cause occlusion in the filter membranes and obstruct the flow.Concerning blood flowing into the bypass line, we infer that a high pressure or load was applied to the collection bag while the filter was occluded, then the check valve in the one-way valve could not withstand the fluid pressure of blood and it resulted in letting blood flowing into the bypass line.

• 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: 19145078
• MDR Text Key: 340857520
• Report Number: 9681839-2024-00012
• 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: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: 231110AF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• 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