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

Model Number N/A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/24/2023

Event Type  Injury  

Event Description

Fresenius kabi received a report from the (b)(6) center stating a donor returned to the center following donation and reported two discolored urines at home.The donor denied any other signs or symptoms.The mss encouraged the donor to increase fluids and seek medical attention from their primary care physician.It was reported that the donor did go to the emergency room, but no additional information on any medical intervention has become available.Although discolored urine is a known possible side effect of plasma donation, fresenius kabi is reporting this event conservatively as it is not known what treatment the donor was given at the emergency room.The batch record for the aurora disposable kit material 4r2256, batch fa23g11260 was reviewed.No exceptions were generated that could classify as a possible root cause.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.

• 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: 17794820
• MDR Text Key: 324006950
• Report Number: 3004548776-2023-00315
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK110072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/21/2023

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: FA23G11260
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2023
• 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