MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AURORA XI PLASMAPHERESIS SYSTEM; AUTOMATED BLOOD CELL SEPARATORS

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/27/2019

Event Type  malfunction  

Event Description

Donor experienced discolored urine after plasma donation.This incident is being reported as the medical device used is the same product code (6r2600) involved in two adverse events filed on august 30, 2019 (mdr report #s 3004548776-2019-00002 and 3004548776-2019-00003) for discolored urine.The cause of discolored urine leading to medical intervention after donating on the fresenius kabi aurora xi plasmapheresis system is still under investigation.However, it was reported as "hemoglobinuria caused by pump tube length" in mdr report #s 3004548776-2019-00002 and 3004548776-2019-00003.Please note, it is in the fresenius kabi aurora xi plasmapheresis system label that donors may experience discolored urine after completing a plasma donation.However, as stated in mdr report #s 3004548776-2019-00002 and 3004548776-2019-00003, 2 separate donors were sent to the hospital and treated (medical intervention).Therefore, we are filing all reports of discolored urine we receive for the fresenius kabi aurora xi plasmapheresis system until our investigation is complete and corrective actions implemented.

Event Description

Reported in initial mdr: donor experienced discolored urine after plasma donation.This incident is being reported as the medical device used is the same product code (6r2600) involved in two adverse events filed on august 30, 2019 (mdr report #s 3004548776-2019-00002 and 3004548776-2019-00003) for discolored urine.The cause of discolored urine leading to medical intervention after donating on the fresenius kabi aurora xi plasmapheresis system is still under investigation.However, it was reported as "hemoglobinuria caused by pump tube length" in mdr report #s 3004548776-2019-00002 and 3004548776-2019-00003.Please note, it is in the fresenius kabi aurora xi plasmapheresis system label that donors may experience discolored urine after completing a plasma donation.However, as stated in mdr report #s 3004548776-2019-00002 and 3004548776-2019-00003, 2 separate donors were sent to the hospital and treated (medical intervention).Therefore, we are filing all reports of discolored urine we have received for the fresenius kabi aurora xi plasmapheresis system until our investigation is complete and corrective actions implemented.Follow-up mdr verbiage: brown/discolored urine occurs due to hemolysis in the concentrated cell lines.The root cause of hemolysis in the concentrated cell lines is excess tubing below the cell pump, which in turn may be due to: (a) distance between purple keepers out of tolerance that could create a kink in the tubing holder joint, or (b) an unfavorable tolerance stack between a cell pump line keeper distance and positioning of the cell pump and its associated tubing guides.The aurora xi instrument currently includes tubing guides that position the plasmacell xi disposable set tubing keepers to ensure consistent pump tubing loading and consistent pump performance.These tubing guides currently grasp the tubing; in some cases, if there is excess tubing between the pump and the tubing guide, kinks may form.The kinked tubing has the potential to cause hemolysis which could result in free hemoglobin being infused to the donor.Current controls: to assure that the distance between the purple keepers is in tolerance, the following controls are established at the manufacturing site: 1) 100%-dimensional inspection is performed during manufacturing process.2) in process visual and dimensional quality inspection.3) process control monitoring per lot.4) post sterilization sampling final inspection.Corrective action: modify the purple keeper assembly fixture to avoid tubing movement and ensure proper distance.This corrective action has been completed.Modify the cell pump tubing guides geometry with a larger bore to allow any potential excess tubing to slip through instead of kinking (fda event reference (b)(4)).Corrective actions were identified based on the fresenius kabi capa 558906 investigation result process.

• Brand Name: AURORA XI PLASMAPHERESIS SYSTEM
• Type of Device: AUTOMATED BLOOD CELL SEPARATORS
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• MDR Report Key: 9226803
• MDR Text Key: 207366360
• Report Number: 3004548776-2019-00020
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• PMA/PMN Number: BK160028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 6R2600
• Device Lot Number: FA19G17107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/27/2019
• Event Location: Other
• Date Report to Manufacturer: 09/27/2019
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1