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

Catalog Number 1BBLGQ456E6

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

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4) (importer) is submitting this report on behalf of (b)(4) factory of terumocorp., (manufacturer).Exemption number: (b)(4).Investigation is still in process.A follow-up report will be provided.

Event Description

The customer reported an elevated white blood cell (wbc) content in the whole blood product.There was not a transfusion recipient or patient involved at the time of the residual wbc testing, therefore no patient information is reasonably known at the time of the event.The whole blood collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer stated that they had an elevated white blood (wbc) content in a filtered whole blood unit that was more than 6x10^6 white blood cells, however, an exact count of the wbc was not provided.The disposable set was not received for evaluation.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.There have been no other similar complaints against this production lot number.Root cause: a definitive root cause could not be determined.No anomalies were noted in the production records.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-SP 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: 6251395
• MDR Text Key: 65231552
• Report Number: 9681839-2017-00004
• Device Sequence Number: 1
• Product Code: CAK
• Combination Product (y/n): N
• Reporter Country Code: NO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/18/2017,01/13/2017

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: 07/31/2018
• Device Catalogue Number: 1BBLGQ456E6
• Device Lot Number: 160222AG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/21/2016
• Device Age: 11 MO
• Event Location: Other
• Date Report to Manufacturer: 01/18/2017
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 01/13/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other