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

Model Number	9400407
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Low Blood Pressure/ Hypotension (1914)
Date of Event	06/08/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
This incident is related to the same patient reported in mdr 3004548776-2026-00296.On (b)(6) 2026, 02:30 pm following complete clinical stabilization, tpe was re-attempted.To evaluate the possibility of albumin-related hypersensitivity, fresh frozen plasma (ffp) was used as replacement fluid instead of albumin.Approximately 20 minutes after initiation of the procedure, after transfusion of one ffp unit and during administration of the second ffp unit, the patient again developed a severe hypersensitivity reaction with cutaneous manifestations and significant hypotension.The procedure was immediately discontinued, and appropriate emergency management was instituted.Prior to the second tpe procedure, the patient received a slow trial infusion of albumin from an alternative manufacturer without any adverse reaction.A separate ffp exposure outside the tpe procedure resulted only in a mild delayed rash over the thigh approximately two hours later, without respiratory compromise or hemodynamic instability.

• Brand Name: FRESENIUS COM.TEC AUTOMATED CELL SEPARATOR
• Common Device Name: PL1 PLASMA EXCHANGE SET INDIA
• 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: 25679332
• Report Number: 3004548776-2026-00295
• Device Sequence Number: 13194493
• Product Code: LKN
• UDI-Device Identifier: 04086000860154
• UDI-Public: 04086000860154
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K060734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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 Model Number: 9400407
• Device Catalogue Number: 9400407
• Device Lot Number: SHA124
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/10/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/12/2025
• 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: Other
• Patient Age: 56 YR
• Patient Sex: Male