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

Catalog Number 1BBWGQ506A2

Device Problems Defective Component (2292); High Test Results (2457); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 09/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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.There was not a transfusion recipient or patient involved at the time of whole blood processing,therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(4).

Manufacturer Narrative

Investigation: one set of blood bags with the filter from the collection set was returned for evaluation.The leukoreduction filter was tested for flow rate and air leaks.A relatively slow flow rate of 20ml/min was noted, and it was confirmed there were no air leaks.The manufacturing records, test records, and inspection records were reviewed for abnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.All membranes conformed to established specification.Shipping testing was performed on the reserve samples from the reported lot number.The reserve samples were also visually examined, and the solution volume and solution composition were tested with no abnormalities noted.All product conformed to the established specification.Root cause: based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the whole blood product could be due to an occlusion, we noticed that the 3rd through 6th filter membranes from the inflow side of the filter were locally dyed dark with toluidine blue.Therefore, occlusion may have occurred, and 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 then leukocyte leakage occurred.As an increase of wbc contamination complaints were noted from previous lot numbers, further investigation was performed.Investigation results indicated that the cause of higher-than-expected wbc content in the whole blood product was due to the maximum pore size of the filter membrane is likely to increase according to the combination of multiple parameters in manufacture of leukoreduction filter membranes and wbc contamination is likely to occur frequently in the product lots of which the maximum pore size of the filter membrane has increased.The instructions for use provide a caution to not squeeze or apply pressure to the filter while it is attached to the bag containing the filtered blood and also to clamp the blood-filled tubing before blood enters the filter in order to avoid leukocyte leakage.Corrective action: an internal capa has been initiated to review the maximum pore size of the filter membrane and the likelihood of an increase according to the combination of the multiple parameters.In addition, the wbc contamination is likely to occur frequently in the product lots of which the maximum pore size of the filter membrane has increased.To achieve a resolution, manufacturing specifications were updated to narrow the range of the parameters in the manufacture of filter membranes and it was confirmed that the appropriate level of the maximum pore size of the filter membrane was achieved.

Manufacturer Narrative

This report is being filed to provide corrected information in f.10 and additional and corrected codes in h.6: method codes are added, corrected codes for results, conclusions and device codes.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya
• MDR Report Key: 7912551
• MDR Text Key: 122313293
• Report Number: 9681839-2018-00051
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/26/2018

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: 05/31/2020
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 171204KK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/05/2018
• Device Age: 10 MO
• Event Location: Other
• Date Report to Manufacturer: 09/26/2018
• Initial Date Manufacturer Received: 09/05/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/26/2018; 11/06/2018
• Supplement Dates FDA Received: 11/01/2018; 11/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other