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 05/17/2023

Event Type  malfunction  

Event Description

The customer reported when beginning filtration blood was passing through the one way purge valve.Donor unit #: (b)(6) 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.Terumo bct is awaiting return of the disposable set for evaluation.

Manufacturer Narrative

Investigation: 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 is assembled by the supplier.The one-way valve used in the bypass line is tested for flowability and leakage for full quantity prior to connecting tubing.Only the valves that have passed the tests are used for assembling of the bypass line.The assembled bypass line is connected to the filter in our manufacturing process, then connected to the sealed bag.We reviewed the manufacturing record of the bypass line assemblies (three lots, 8178 sets in total) that were used for the product concerned, and there were no abnormalities.We also reviewed the test records of appearance, flowability, and leakage of the one-way valve; however, no abnormalities were observed.Release testing, including a visual 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 lot number in question to perform a reproducibility test with the use of colored normal saline.We confirmed that the normal saline did not flow into the collection bag by passing beyond the one-way valve in each sample.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 final product lots (six lots, that is, 8145 sets in total) that used the same one-way valve lot (one-way valve lot: 220624md), 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 (b)(6), 2023.Root cause: from the above-mentioned investigations, there were not any abnormalities in the manufacturing records or testing records, including the supplier.Therefore, we were not able to identify the cause of the issue.When high pressure is applied, fluid is likely to pass beyond the valve concerned and avoid applying pressure to the primary bag during filtration process.

Event Description

The customer reported when beginning filtration blood was passing through the one way purge valve.Donor unit #: (b)(4) 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.

Manufacturer Narrative

This report is being filed to provide additional information in h.3, h.6 and h.10.Corrected information is provided in h.10.Investigation: we conducted the following investigation on the returned set, which we received we observed the set and confirmed that the one-way valve and filter set were aligned in the correct direction.We also confirmed that air was already expelled from the primary bag.The returned set was suspended from an iv stand.The collection bag was filled with 570 ml of normal saline and filtration was performed by gravity.We confirmed that normal saline did not pass through the valve.We observed a relatively slow flow rate, which was about 23 ml/min.We disassembled the one-way valve and observed the slit in the built-in valve by magnification.The observation revealed no abnormalities.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 is assembled by the supplier.The one-way valve used in the bypass line is tested for flowability and leakage for full quantity prior to connecting tubing.Only the valves that have passed the tests are used for assembling of the bypass line.The assembled bypass line is connected to the filter in our manufacturing process, then connected to the sealed bag.We reviewed the manufacturing record of the bypass line assemblies (three lots, 8178 sets in total) that were used for the product concerned, and there were no abnormalities.We also reviewed the test records of appearance, flowability, and leakage of the one-way valve; however, no abnormalities were observed.Release testing, including a visual 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 lot number in question to perform a reproducibility test with the use of colored normal saline.We confirmed that the normal saline did not flow into the collection bag by passing beyond the one-way valve in each sample.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 final product lots (six lots, that is, 8145 sets in total) that used the same one-way valve lot (one-way valve lot: 220624md), 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 june 19, 2023.Corrected root cause: we reviewed the manufacturing record, inspection record, testing record, and retained samples of the lot concerned.It was confirmed that there were no abnormalities.With the returned set, we were not able to reproduce the liquid passing through one-way valve during filtration process.We also confirmed in the set that the slit in the built-in valve was normal.Therefore, we were not able to identify the cause of the issue.Regarding liquid (blood) passing through the one-way valve, the following factors may cause the event.(1) pressure or load was applied to the primary bag during filtration blood flows backward when pressure is applied to the primary bag during filtration, then the bypass line is filled with blood, and it may cause blood passing through the one-way valve.It would be appreciated if you could pay attention to avoid applying pressure to the primary bag during filtration.(2) blood flow was inadequate during filtration when the cliktip of the collection bag is not fully broken or it gets in the upper part of the cover tube of the tube joint, or when there is aggregation due to blood component in the collection bag, blood flow path is blocked and it causes inadequate blood flow, thus blood may pass through the bypass line.When breaking the cliktip, snap the cliktip firmly back and forth with the fingers, then rub the tube joint gently several times to avoid having the cliktip get into the upper part of the cover tube.

• 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: 17203875
• MDR Text Key: 317915154
• Report Number: 9681839-2023-00042
• 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,Followup
• Report Date: 06/26/2023

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: 02/29/2024
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 220902AF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2023
• Initial Date FDA Received: 06/26/2023
• Supplement Dates Manufacturer Received: 07/03/2023
• Supplement Dates FDA Received: 07/21/2023
• 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