MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM; FOR COLLECTION OF VIRTUALLY CELL FREE PLASMA BY MEMBRANE FILTRATION. FOR USE WIT

Model Number	4R2256
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/19/2024
Type of Reportable Event	Death
Event or Problem Description
On (b)(6) 2025 biolife plasma services received telephone notification of a donor death.The chief medical examiner in (b)(6) noted the donor had died at his home on (b)(6) 2024.The chief medical examiner related that no cause of death was known and initiated a request for biolife records.A review of donor records shows the donor last donated on (b)(6) 2024.The biolife center physician contacted the medical examiner's office on (b)(6) 2025 and was informed that while the cause of death is not known that a history of nausea, vomiting and cephalgia were noted after plasmapheresis and that unspecified hyponatremia was also noted.Upon notification of the donor's death, the plasmapheresis device was taken out of service.The plasmapheresis device logs and single use collections materials records were inspected and no aberrant findings were noted.The preventative maintenance tpds was performed on (b)(6) 2025 and found the instrument to be working as intended.In conclusion, the death of the donor, occurring shortly after a plasma donation at biolife plasma services, the reported symptoms of nausea, vomiting, cephalgia, and unspecified hyponatremia noted by the medical examiner.However, a definitive causal relationship between the plasmapheresis procedure and the donor's death cannot be determined at this time due to the lack of detailed autopsy records.The investigation of the donation procedure and equipment revealed no immediate anomalies.Per biolife, the donor did not relate a history of prior electrolyte abnormalities but did note a resolved history of kidney stones.As no further medical or autopsy records are currently available, no causal relation between the plasmapheresis procedure and the fatality can be determined.Further investigation by fresenius kabi is pending.Given that the donor died one day after the final uncomplicated donation and the cause of the death is currently unknown, we are reporting this incident conservatively.
Event or Problem Description
No kit sample or picture were available for analysis.Therefore, the customer reported complaint cannot be confirmed and a root cause cannot be identified.The following current controls are in place to assure integrity of the kit 1) in process sampling quality inspection and 2) post sterilization sampling final inspection.Additionally, the batch record for kit batch fa24d12074 was reviewed.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 testing and product testing.The reported death occurred in (b)(6) 2024, but was not reported to fresenius kabi until april 2025.Therefore, no procedure records nor system data logs were available for analysis.The fse (field service engineer) stated the tpds (test procedure data sheet) was completed.The fse stated that the device passed all testing after the part was replaced.There is no indication of a device malfunction.A device history review of the device serial number (b)(6) was conducted in order to identify potential related manufacturing non-conformances.The review yielded no non-conformances related to this issue.A review of the service records for this device, serial number (b)(6) found no same/similar complaints related to this one.A search of capas found no related issues.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints for the corresponding defect category or to determine if corrective actions are needed.No adverse trend was observed in the last product review meeting performed before this complaint was received.Fresenius kabi has determined that the device did not contribute to the donor's death.

• Brand Name: FENWAL PLASMACELL-C DISPOSABLE SET FOR USE WITH SPIKESMART SYSTEM
• Common Device Name: FOR COLLECTION OF VIRTUALLY CELL FREE PLASMA BY MEMBRANE FILTRATION. FOR USE WIT
• 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: 22044025
• Report Number: 3004548776-2025-00257
• Device Sequence Number: 8899289
• Product Code: GKT
• UDI-Device Identifier: 00810020441116
• UDI-Public: 00810020441116
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: BK110072
• 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 Expiration Date: 04/30/2026
• Device Model Number: 4R2256
• Device Catalogue Number: 4R2256
• Device Lot Number: FA24D12074
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/19/2025
• Supplement Report FDA Received Date: 08/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/12/2024
• 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: Death
• Patient Sex: Unknown