MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM; FOR COLLECTION OF VIRTUALLY CELL FREE PLASMA BY MEMBRANE FILTRATION. FOR USE WIT

Model Number	4R2256
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hemolysis (1886); Hematuria (2558); Renal Impairment (4499)
Date of Event	07/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Fresenius kabi canada reported an incidence of hemolytic plasma during a donation on the aurora plasmapheresis system.The donor experienced symptoms of hemolysis such as flank pain, discolored urine and kidney-related complications that required a 10-day hospitalization.Samples have been returned for evaluation and the device log files are being reviewed.A follow-up mdr will be filed once the investigation of this event is complete.
Event or Problem Description
No sample or picture was available for analysis.The following probable root causes have been identified: 1) rough surface finish of the roller pins, 2) kink, squeeze or twisted tubing created by the pump, 3) stopped roller inside the pump.The following corrective actions were defined: 1) improved detection of roller cages at risk of having a stuck roller, 2) improvement of current roller pin surface finish, 3) instruct operators and service technicians not to use lubricants on the roller cages.Although discolored urine is a known possible side effect of plasma donation, fresenius kabi reported this event conservatively as it is not known what treatment the donor was given at the emergency room.
Additional Manufacturer Narrative
Section b5 corrected to match investigation completed by manufacturer.Section d corrected to match gudid.
Event or Problem Description
This report is being submitted as a correction to the previous follow-up mdr.The customer reported that a donor presented with hemolysis symptoms such as flank pain, discolored urine and kidney-related complications that required a 10-day hospitalization after plasma donation.During the donation, the machine sounded "hb detected" alarm, the donation staff that attended to the alarm removed the plasma line from the hb sensor and resumed the procedure; the line was never put back in place, the full donation was collected.No device or kit samples were made available for evaluation.The device was serviced by service technicians from the customer site, not by fresenius kabi service personnel.The self service technician performed tpds (test procedure data sheet) on the machine and found all parameters acceptable and did not proceed with any further maintenance or repair.From available records of the event, during the procedure staff assessed the color of the plasma at the time of the hb alarm.From staff assessment during the procedure, the plasma was of acceptable color at the time of alarm, and thus staff cleared the alarm to continue the procedure.It was stated that the staff removed the tubing from the hb detector to avoid the possibility of more alarms.The tubing was not replaced, and the donation was completed.Following collection, the unit was found to be unacceptable in color by the staff.The onsite aurora technician performed tpds on the machine and found all parameters acceptable and did not proceed with any further maintenance or repair.The device was released for use.A review of the complaint records for this device, serial number (b)(6) found no same/similar complaints.A device history review for manufacturing non-conformances was completed and no related non-conformances were found.A search of capas found no related issues.The results of the investigation determine that the complaint was confirmed.The problem statement mentions that the device alarmed due to a color change in the plasma line, but the plasma line was removed from the hb sensor by the operator and the procedure was resumed.This user action bypasses an important safety system to prevent hemolysis.The cause of the reported hemolysis was most likely linked to the actions of the customer as they had operated the device against the operator's manual instructions.No issue was found with the device when evaluated by an onsite service technician via execution of tpds (test procedure data sheet).Although discolored urine is a known possible side effect of plasma donation, fresenius kabi reported this event conservatively as it is not known what treatment the donor was given at the emergency room.

• Brand Name: FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM
• Common Device Name: FOR COLLECTION OF VIRTUALLY CELL FREE PLASMA BY MEMBRANE FILTRATION. FOR USE WIT
• Manufacturer (Section D): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer (Section G): FENWAL INTERNATIONAL INC.; carretera sanchez km 18.5; parque industrial itabo zona f; haina, san cristobal, ; DR
• Manufacturer Contact: rebecca mccandless ; 3 corporate drive; lake zurich, IL 60047 ; 8475502300
• MDR Report Key: 17837176
• Report Number: 3004548776-2023-00335
• Device Sequence Number: 7418219
• Product Code: GKT
• UDI-Device Identifier: 04086000101356
• UDI-Public: 04086000101356
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: BK110072
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Expiration Date: 03/31/2025
• Device Model Number: 4R2256
• Device Catalogue Number: 4R2256
• Device Lot Number: FA23C29394
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/28/2023
• Supplement Report FDA Received Date: 09/25/2024; 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/29/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Sex: Unknown