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

Patient Problem No Patient Involvement (2645)

Event Date 12/12/2016

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 cells (wbcs) in the filtered whole blood unit.Donor (b)(6) there was not a transfusion recipient or patient involved at the time of unit processing,therefore no patient information is reasonably known at the time of the event.

Manufacturer Narrative

Investigation: a red blood cell (rbc) storage bag was received for evaluation.However,an evaluation could not be performed since the filter was not returned for evaluation and the reported event is related to a filtration issue.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(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 ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6237772
• MDR Text Key: 64734441
• Report Number: 9681839-2017-00002
• 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: 02/17/2017,01/10/2017

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: 11/30/2018
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 160613KK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/16/2016
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/17/2017
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 02/03/2017; 02/22/2017; 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2016
• 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