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

Catalog Number 1BBWGQ506A2

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 05/01/2023

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.For the leukoreduction 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.Review of the manufacturing record of the lot number in question was performed.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the standards.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.Three sets of retained samples of the lot number concerned were visually inspected.There were no abnormalities, such as tubing occlusion and blockage, in their appearances.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.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.

Event Description

The customer reported elevated white blood cell (wbc) content in a filtered whole blood unit.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.

Manufacturer Narrative

Investigation: investigation results of the set returned the filter of the set was rinsed with normal saline.The normal saline flowed through the filter at a slow flow rate of about 10 ml/min.An airtightness test (i.E.Leak test) was performed on the filter in accordance with the following procedures and we confirmed that air leaks were not observed in any locations of the filter.I) the tab sheet covering the outlet side (second side) of the filter is cut out carefully and exposed the outlet side to allow observing the frame sheet (partition) directly.Ii) air is admitted to the filter, which is submerged in water, from the outlet-tube of the filter at a gauge pressure of 39.2 kpa (0.4 kgf/cm2) for about 10 seconds to check whether there is any air leakage from the frame sheet (partition).We disassembled the rinsed filter to observe the appearance of filter media (membranes).We noticed creases in the filter media; however, the creases were not different from those observed in conforming products.We did not observe aggregates adhered to the filter media.After passing normal saline through the filter, we dyed the filter media with toluidine blue for observation.We noticed that the first through third filter membranes from the inlet side of the filter were dyed dark, that is, white blood cells were accumulated in these dark dyed areas.With regard to three sets of the retained samples of the lot number concerned, we measured the volume and concentration of the solution in the same manner as the release testing.We did not see any abnormalities, and the results conformed to our in-house standards.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.For the leukoreduction 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.Review of the manufacturing record of the lot number in question was performed.In addition, we investigated dope material used for the lot number in question and found that the viscosity of pu solution of dope material conformed to the standards.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.Root cause: as the investigation results provided in our initial answer card, no abnormalities were observed in the manufacturing record or the testing and inspection record of the lot number concerned.We also investigated the retained samples of the lot number concerned, and the results revealed no abnormalities.In the investigation of the filter of the set returned, the flow rate of normal saline through the filter was slow, and the first through third filter membranes from the inflow side were dyed dark with toluidine blue; therefore, occlusion caused by white blood cell or platelet aggregates may have occurred in the filter.In this case, blood may have been filtered by the filter area which was smaller than usual, and the linear speed (flow rate per unit area) increased and consequently leukocyte leakage occurred.

• 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 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: 17004209
• MDR Text Key: 316789230
• Report Number: 9681839-2023-00035
• 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: 05/25/2023

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 Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 220921AF
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 06/02/2023
• Supplement Dates FDA Received: 06/19/2023
• 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