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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Patient Involvement (2645)

Event Date 11/21/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is in process.A follow-up report will be provided.

Event Description

Customer is reporting an elevated white blood cell (wbc) count 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 #: (b)(6).Terumo bct is awaiting the return of the whole blood set.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation is still in process.A follow-up report will be provided.

Event Description

The whole blood collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the collection set was not available for return for evaluation.The manufacturing and testing records were reviewed for this lot number.No abnormalities were noted in the records that would have contributed to the issue.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 (not resting the collected blood prior to filtering; not expressing air properly from the product bag) 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 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 ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6178763
• MDR Text Key: 62866566
• Report Number: 9681839-2016-00008
• 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,Followup,Followup
• Report Date: 12/28/2016,12/15/2016

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: 12/31/2018
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 160719KK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 11/23/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2016
• Initial Date Manufacturer Received: 11/23/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 01/26/2017; 01/26/2017; 02/15/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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