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	Anaphylactic Shock (1703); Tachycardia (2095); Low Oxygen Saturation (2477); Wheezing (4463)
Date of Event	06/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, 10:00 am, a therapeutic plasma exchange was initiated using the com.Tec system with 5% albumin (plasmagen®) as replacement fluid.Approximately 15 minutes after initiation of the procedure, the patient developed a severe hypersensitivity/anaphylactoid reaction characterized by wheezing, stridor, oxygen desaturation, generalized urticaria/hives, flushing, facial puffiness, tachycardia, and severe hypotension (blood pressure decreased from approximately 140/90 mmhg to 80/60 mmhg).The procedure was immediately discontinued.The patient was treated with adrenaline 0.1 mg, hydrocortisone 100 mg iv, pheniramine maleate (avil®) 1 ampoule iv and gelofusine® 500 ml bolus.Supplemental oxygen via face mask.The patient subsequently stabilized.

• 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: 25679331
• Report Number: 3004548776-2026-00296
• Device Sequence Number: 13194492
• 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: SHA 124
• 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