MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8480
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	10/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Pm testing was performed onsite by baxter technical support staff with (new) iv tubing set (product code: 2r8480 / non-dehp) with passing results for two runs: 40ml/hr with a volume to be infused of 20ml.Run 1 output was 20.9ml (pass), run 2 output was 20.9ml (pass).A third run was performed using the type of set used during the reported event (product code: 2r8480 / non-dehp) with an output of 19.9ml (pass).A video was taken by facility staff only showing the drip chamber likely during the loading bolus.An additional video was taken by baxter staff during the testing that shows higher rate drops in the drip chamber during a drug/loading dose of a rate of 618ml/hr.During simulated drug delivery at a rate of 33.3ml/hr.There is a slower drip rate observed in the drip chamber.The actual set used during the event along with the infusion pump was retained by the facility and will be returned to baxter for evaluation.
Event or Problem Description
It was reported that a spectrum iq infusion pump infused amiodarone at a significantly accelerated rate, which did not align with the programmed dosage.A clearlink, non-dehp solution set was used to administer the medication.It was alleged the patient had subsequently passed away.The event occurred in the critical intensive care unit (cicu).The pump was programmed to infuse amiodarone (450mg, 1.8mg/ml) at a rate of 33.33ml/hour or 1mg/minute for a volume to be infused of 250ml at room temperature.The amiodarone bag size was 250ml.The infusion was supposed to last 7.5 hours but infused in less than 3 hours on the first bag and less than 2 hours on the second bag.The clearlink was in use for 2 hours with no iv set add-on components used.The administration set upstream of the pump did not appear collapsed or deformed.It was further reported that there were other infusion systems connected at the same access point; however, no specific information was provided.It was not reported if any life sustaining treatment was provided or if an autopsy was performed.The cause of death was not provided.No further information is expected regarding patient¿s medical condition, past medical history, or cause of death, including autopsy results.
Additional Manufacturer Narrative
Additional information was added to d9, h3, h4 and h6.H4: device manufacture date - the lot was manufactured between november 25-26, 2024.H11: two (2) actual devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.All components are correctly placed and according to specifications.Pressure test and clear passage under water were performed, and the results were satisfactory.Priming was performed, and no issues were noted.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/DUO-VENT
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; parque industrial de cartago; apartado no. 1-7052; cartago ; CS
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23659076
• Report Number: 1416980-2025-05866
• Device Sequence Number: 15966395
• Product Code: FPA
• UDI-Device Identifier: 00085412565750
• UDI-Public: (01)00085412565750(10)R24K23017(17)261122
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2R8480
• Device Catalogue Number: 2R8480
• Device Lot Number: R24K23017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2025
• Supplement Date Received by Manufacturer: 12/17/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 12/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AMIODARONE; SPECTRUM IQ PUMP
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown