MAUDE Adverse Event Report: FENWAL INTERNATIONAL INC. PLASMACELL XI DISPOSABLE SET WITH SPIKESMART; FOR COLLECTION OF PLASMA BY MEMBRANE FILTRATION. FOR USE WITH THE AURORA XI INST

Model Number	6R2600P
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	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
Fresenius kabi received a report from a (b)(6), regarding a donor-reported adverse event associated with a prior donation.The donor, a 54-year-old female, presented for plasmapheresis donation on (b)(6) 2025.During the pre-donation screening, she disclosed that she had previously been hospitalized for a lung clot following her donation at the same center on (b)(6) 2025.She stated that she was admitted to (b)(6) hospital, where she remained hospitalized from on (b)(6) 2025, and was discharged with a prescription for eliquis (an anticoagulant).(b)(6) currently does not have access to any medical records or hospital documentation to confirm this report.The donor declined to provide discharge paperwork or other clinical documentation when asked by center staff.Review of the donor's history indicates that she donated again on (b)(6) 2025 without disclosing her recent hospitalization or anticoagulant use.That donation was completed successfully and uneventfully.No complications during or following on (b)(6) 2025 donation were reported by the donor or the center.On (b)(6) 2025, the donor presented to the center for another donation and disclosed her medical history to the attending nurse.The donor was subsequently deferred by the center medical director, and no donation occurred on that date.The donation on (b)(6) 2025, the date of the reported lung clot, was reported as unremarkable during the procedure itself.However, while waiting in the reception area post-donation, the donor experienced a minor hypotensive reaction characterized by flank pain and a general feeling of being unwell.She received appropriate on-site care and was discharged in good condition.The procedure was completed without incident, the appropriate amount of anticoagulant was administered, and no equipment malfunction or procedural deviation was reported.The aurora xi device used during on (b)(6) 2025 donation remains at the center but has not been used since the event.A fresenius kabi field service engineer (fse) visited the site and completed a test procedure data sheet (tpds).The device was found to be operating as intended, and no issues were identified during testing.The center's corporate medical department officially closed their internal case on (b)(6) 2025 following completion of this evaluation.A backup sample from the donor's on (b)(6) 2025 donation remains available.While no sample or unit is available from on (b)(6) 2025 donation, and no donation occurred on (b)(6) 2025, a request has been initiated to retrieve on (b)(6) 2025 sample for evaluation.Further investigation by fresenius kabi is pending.Given that the donor's reported lung clot is a serious event, and no medical records were provided, we are reporting this incident conservatively.Based on the available information, including an uneventful procedure and a minor post-donation hypotensive reaction, the reported event may represent a coincidental occurrence unrelated to the procedure or device.
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.The batch record for batch fa25c21035, material 6r2600p 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 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: PLASMACELL XI DISPOSABLE SET WITH SPIKESMART
• Common Device Name: FOR COLLECTION OF PLASMA BY MEMBRANE FILTRATION. FOR USE WITH THE AURORA XI INST
• 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: 22924100
• Report Number: 3004548776-2025-00498
• Device Sequence Number: 21141109
• Product Code: GKT
• UDI-Device Identifier: 00810020441116
• UDI-Public: 00810020441116
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: BK160028
• 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): 01/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: 6R2600P
• Device Catalogue Number: 6R2600P
• Device Lot Number: FA25C21035
• 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: 08/01/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/29/2025
• Supplement Report FDA Received Date: 01/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/21/2025
• 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: Required Intervention
• Patient Sex: Unknown