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

Catalog Number 1BBLGQ506A6

Device Problems Defective Component (2292); Free or Unrestricted Flow (2945)

Patient Problem No Patient Involvement (2645)

Event Date 02/09/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during whole blood unit filtration, the bypass valve did not prevent blood from going through the bypass line, resulting in possible wbc contamination.Customer stated plasma products were made, but not red cells and platelets.Wbc count is not available at this time.There was not a transfusion recipient or patient involved at the time of the residual white blood cell (rwbc) testing, therefore no patient information is reasonably known at the time of the event.Donor unit #: (b)(6).

Manufacturer Narrative

Investigation: the one-way valve was returned for evaluation.Upon magnified visual inspection, a jagged slit was observed in the built-in valve.Manufacturing and testing/inspection records were reviewed for this lot.No abnormalities were noted in the records that would have contributed to the issue.Five retention samples from this lot were tested for flow and no issues were noted with the samples.The valve assembly is purchased from a supplier.The valve was sent to the supplier for evaluation.The supplier identified an issue during production of the valve lot in question as the reason for the jagged slit.Root cause: the cause of the blood back-flow as experienced by the customer was determined to be a manufacturing defect of the one-way valve by the valve supplier.Corrective action: the supplier corrected the machine issue that caused the defect and introduced a visual-check step in the manufacturing process.Additionally, the supplier has changed the frequency of the maintenance on the slit mold.

• 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: 6412614
• MDR Text Key: 70451470
• Report Number: 9681839-2017-00056
• Device Sequence Number: 1
• Product Code: KSR
• 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
• Type of Report: Initial,Followup
• Report Date: 03/20/2017,03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2017
• Device Catalogue Number: 1BBLGQ506A6
• Device Lot Number: 160728AF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/21/2017
• Device Age: 8 MO
• Event Location: Other
• Date Report to Manufacturer: 03/20/2017
• Date Manufacturer Received: 03/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/30/2016
• 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