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

Catalog Number 1BBWGQ506A2

Device Problems High Test Results (2457); Filtration Problem (2941)

Patient Problem No Patient Involvement (2645)

Event Date 05/16/2017

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 the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #:(b)(6).

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: one set of blood bags was received for evaluation.The leukoreduction filter was tested for flow rate and air leaks.A slow flow rate 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.Root cause:a definitive root cause for the observed elevated wbc count remains undetermined at this time.Based on the available information, it cannot be ruled out that the higher-than-expected wbc content in the whole blood product could be donor-related (characteristics of blood).It also cannot be ruled out that a filtering error or other process error (the physical stress on filter membranes is greater than what is expected, trapped leukocytes are pushed out of the filter membranes) could have contributed to the higher-than-expected wbc content in the whole blood product.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 to clamp the blood filled tubing before blood enters the filter in order to avoid leukocyte leakage.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya
• Manufacturer Contact: steve kern ; 10810 w. collins ave.; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6621987
• MDR Text Key: 77499913
• Report Number: 9681839-2017-00088
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2017,06/08/2017

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: 04/30/2019
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 161121KK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/17/2017
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2017
• Initial Date Manufacturer Received: 05/17/2017
• Initial Date FDA Received: 06/08/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 06/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2016
• 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