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 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

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.The 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 in h.6 and h.10.Investigation: the blood bag set was not returned for evaluation.The manufacturing records, test records, and inspection records were reviewed forabnormalities and none were found.The records regarding the particulate removal rates of the filter membranes were reviewed.Allmembranes conformed to established specification.Shipping testing was performed on the reserve samples from the reported lot number.Thereserve samples were also visually examined, and the solution volume and solution compositionwere tested with no abnormalities noted.All product conformed to the establishedspecification.The reported lot number was evaluated and it was determined that the same incidentassociated with this event had not been reported by other medical institutes as of october 24,2019.Root cause: we reviewed the manufacturing record and the testing and inspection record ofthe reported lot number; however, we did not find any abnormalities and we were not able toidentify the cause of the issue.

Manufacturer Narrative

This report is being filed to provide additional information in e.3.And corrected information in h.10.Corrected root cause: we reviewed the manufacturing record and the testing and inspection record of the reported lot number; however, we did not find any abnormalities and we were not able to identify the cause of the issue.In addition, as stated in the issue description of the quality notification, the unit was not clamped off when evacuating air from the primary bag and this could cause 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
• MDR Report Key: 9208623
• MDR Text Key: 182546752
• Report Number: 9681839-2019-00060
• 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: 10/18/2019

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: 03/31/2021
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 181031AH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 09/24/2019
• Initial Date FDA Received: 10/18/2019
• Supplement Dates Manufacturer Received: 10/28/2019; 01/08/2020
• Supplement Dates FDA Received: 11/12/2019; 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other