MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. AURORA PLASMAPHERESIS SYSTEM

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hemolysis (1886); Hematuria (2558); Renal Impairment (4499)

Event Date 07/15/2023

Event Type  Injury  

Event 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.

• Brand Name: AURORA PLASMAPHERESIS SYSTEM
• Type of Device: AURORA PLASMAPHERESIS SYSTEM
• 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
• MDR Text Key: 324513684
• Report Number: 3004548776-2023-00335
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: BK110072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2023

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
• Device Operator: Other
• Device Model Number: N/A
• Device Catalogue Number: 4R2256
• Device Lot Number: FA23C29394
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/29/2023
• 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): Hospitalization