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

Catalog Number 1BBWGQ506A2

Device Problem Material Integrity Problem (2978)

Patient Problem Hemolysis (1886)

Event Date 05/07/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation: per the customer, the units were processed and the alleged hemolysis was observed in the plasma post centrifugation.The disposable sets were not returned for evaluation.The manufacturing records, test records and inspection records were reviewed for this lot.No anomalies were noted and the product conformed to current established specifications.No similar reports have been received regarding this lot number.Three retention samples from this production number were visually examined.One bag was tested for solution volume and the other two were tested for the composition of the solution.There were no abnormalities in appearance and measured values conformed to in-house standards.Investigation of the manufacturing change control history for the past two years confirmed that the specification for the cationizing agent had been increased.This change had been implemented, to allow greater stability in production.Hemolysis testing was performed to investigate the impact of the cationizing agent.Investigation results indicate that the cationization level of the filter which was integrated into the sterilized product increased and the concentration of free hemoglobin in whole blood increased.The distribution width of the cationization level of actual filters were reviewed and found that it was possible that the width of the cationization level of actual filters is causing the hemolysis the control method of the average cationization level was changed to a new control method.Root cause:the following root causes were determined:-as a result of the increase in the amount of the cationizing agent, the cationization level of the filter which was integrated into the sterilized product, increased.-the distribution width of the average cationization level of the combination of filter membranes was wide and showed some filter membranes of which the average cationization level was high.Corrective action:the following corrective actions were implemented:-the amount of the cationizing agent was restored to the previous manufacturing specifications.-a new filter control method was created, and the control criteria of the average cationization levels was reduced.

Event Description

The customer reported that they had 19 units of plasma derived from whole blood with a red tinge they believe is due to hemolysis.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.Donor (b)(6).The disposable sets are not available for return because they were discarded by the customer.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Type of Device: IMUFLEX WB-RP BLOOD BAG SYSTEM WITH LR FILTER
• Manufacturer (Section D): TERUMO CORPORATION/TERUMO BCT; fujinomiya
• Manufacturer Contact: glenda o'neill ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 5070712
• MDR Text Key: 26120123
• Report Number: 1722028-2015-00523
• 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
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 141125KK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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