MAUDE Adverse Event Report: TERUMO CORPORATION/TERUMO BCT IMUFLEX BLOOD BAG SYSTEM; IMUFLEX FILTER BLOOD BAG SYSTEM

Catalog Number	1BBWGQ456G6
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	03/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) investigation is in process.A follow-up report will be provided.
Event or Problem Description
The customer reported that they had 10 units of whole blood that were hemolyzed following filtration.There were no transfusion recipients or patients involved at the time of whole blood processing, therefore no patient information are reasonably known at the time of the event.The disposable kit is not available for return, because it was discarded by the customer.
Additional Manufacturer Narrative
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, and testing 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.A box of unused collection sets (b)(4) was returned for evaluation.(b)(4) sets were tested for cationization levels of the filter membranes and it was confirmed that the levels were within acceptable standards.Root cause: no defect samples were available for investigation and the cause of the incidents was not able to be definitively identified; however, the reported filtration time appears to be within the allowable range of the product.There are two major factors of occlusion during filtration: "occlusion in the tubing" and "occlusion in the filter".The following are possible causes of occlusion.Click tip is not fully broken - if click tip is not fully broken, a hole is partially opened thus a user cannot obtain enough blood volume.Click tip gets into the joint of the donor tube in the upper part of the cover tube when breaking the click tip.Kink in tubing.Clots obstruct the tubing and filter - if blood clots (or aggregates) are formed in an unfiltered bag for some reason, the clots flow into the fluid path and the filter and cause the obstruction of the flow.Insufficient mixing of blood in unfiltered bag before filtration if the bag stands still between the time of blood collection and filtration, red cells in the bag are spontaneously precipitated and concentrated.The concentrated portion of red cells increases viscosity and may occlude the filter.Hemolysis is commonly caused by the following factors: characteristics of blood.Bacterial contamination.Excessively cooling.Filter clogging.

• Brand Name: IMUFLEX BLOOD BAG SYSTEM
• Common Device Name: IMUFLEX FILTER BLOOD BAG SYSTEM
• Manufacturer (Section D): TERUMO CORPORATION/TERUMO BCT; fujinomiya
• MDR Report Key: 5580975
• Report Number: 1722028-2016-00244
• Device Sequence Number: 46202
• Product Code: CAK
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 1BBWGQ456G6
• Device Lot Number: 150707AG
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/15/2016
• Supplement Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other