MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR; COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET

Model Number	9400408
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Anaphylactic Shock (1703)
Date of Event	05/14/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
At 9:20 am on (b)(6) 2025, the patient was undergoing treatment for guillain-barré syndrome.During the plasma exchange process, the patient experienced anaphylactic shock.The patient improved after emergency treatment and symptomatic management, which included the use of dexamethasone, diphenhydramine, and adrenaline.This adverse event caused temporary harm to the patient and required hospitalization.The patient had undergone plasma exchange once on (b)(6) 2025 without any transfusion reaction.The patient also had no history of blood transfusion or transfusion reactions.Submitting conservatively as this product is similar to a device distributed in the united states.
Event or Problem Description
No sample or picture were available for analysis.Without the proper sample or picture evaluation is not possible to determine the probable root cause of the reported failure.The customer complaint is not confirmed.Root cause cannot be identified based on the kit autopsy, as there is no sample or picture available for evaluation.The batch record was reviewed, and no exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process and product testing.

• Brand Name: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
• Common Device Name: COM.TEC PL1 RED CELL / PLASMA EXCHANGE SET
• 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 ; 8475502913
• MDR Report Key: 22189119
• Report Number: 3004548776-2025-00284
• Device Sequence Number: 8870691
• Product Code: LKN
• UDI-Device Identifier: 04086000860154
• UDI-Public: 04086000860154
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K060734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2025

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: Health Professional
• Device Model Number: 9400408
• Device Catalogue Number: 9400408
• Device Lot Number: PLA 282
• 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: 05/20/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/11/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/28/2024
• 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