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 No Information (3190)

Event Date 01/28/2015

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.No problems were noted during the collection.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that they had one unit 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.(b)(6).Disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the disposable set was 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 production 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.Root cause: the reported incident may have occurred from a combination of the following common factors ofred-tinged blood products: characteristics of blood.Bacterial contamination.Excessively cooling.Filter occlusion.

• 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: 5072344
• MDR Text Key: 26076978
• Report Number: 1722028-2015-00543
• 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: 08/31/2017
• Device Catalogue Number: 1BBWGQ506A2
• Device Lot Number: 150330KK
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/06/2015
• 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