MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2C8671
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hypoglycemia (1912); Irritability (2421)
Date of Event	03/18/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Baxter received one (1) used primary iv set connected to an extension set for evaluation of a reported leak condition.At the time of the complaint, the customer did not provide a baxter product code or lot number for either set.Based on the overall length, configuration, and componentry, the extension set was identified as 2c8671, and the primary set was identified as 2c8537 or 2r8537.A visual inspection was performed on the returned sample using the unaided eye.All components were present, properly assembled, and consistent with design specifications.No visible defects, damage, or abnormalities were observed on either the primary or extension set.The sample was evaluated in the configuration received, with the primary set connected to the extension set.During functional testing, the set flowed as intended, and no leaks were observed during priming from any components of the primary or extension set.Pressure test and clear passage (underwater) test was performed with the extension set connected to the primary set, matching the configuration received.No sustained bubble formation, leakage, or pressure loss was observed during testing.The test results were satisfactory.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified baxter access set leaked from an unspecified location during a total parenteral nutrition (tpn) infusion.The patient became acutely agitated despite fentanyl treatment, prompting the registered nurse to assess the intravenous (iv) line, at which time leakage of the tpn was identified.The tubing was deemed unreliable and discontinued, and the provider ordered dextrose containing iv fluids in place of the tpn.Blood glucose levels were monitored, and the patient was subsequently found to be hypoglycemic and required a 10% dextrose (d10) bolus.No additional information is available.
Additional Manufacturer Narrative
Upon visual inspection, functional evaluation, and pressure testing performed under representative use conditions, the reported leak condition could not be confirmed.No evidence of product nonconformance was identified in the returned sample.Based on the currently reported information and the sample analysis, the baxter access set was determined not to be a factor in the reported event of patient was hypoglycemic necessitating medical intervention.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
Additional information was added to d1, d2, d4, d9, g4 and h4.Corrections were made to h6 and h11.D4 udi: as the lot # is unknown, the udi will consist of the primary di number only.H11: the device was received for evaluation.Visual inspection on the actual sample did not identify any abnormalities that could have contributed to the reported condition.A functional leak test was performed, and no signs of a leak were observed from the device.A pressure test and underwater test was performed with the extension set connected to the primary set, matching the configuration received.No sustained bubble formation, leakage, or pressure loss were observed during testing.The test results were satisfactory.A static hold was performed by priming the set and clamping off the end of the distal end of the extension set.Once fully primed a dynamic leak was noted immediately from the from the gland of the clearlink on the extension sets.The reported condition was verified.The cause of the reported condition could not be determined.Although sample analysis confirmed the presence of a leak, the device malfunction is unlikely to have directly caused or contributed to the patient¿s hypoglycemia requiring medical intervention, as the affected line was identified as infusing tpn.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24973814
• Report Number: 1416980-2026-01442
• Device Sequence Number: 4979064
• Product Code: FPA
• UDI-Device Identifier: 00085412046334
• UDI-Public: (01)00085412046334
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 06/23/2026

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?: Yes
• Operator of Device: Other
• Device Model Number: 2C8671
• Device Catalogue Number: 2C8671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/20/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Supplement Date Received by Manufacturer: 04/23/2026; 05/25/2026
• Initial Report FDA Received Date: 04/23/2026
• Supplement Report FDA Received Date: 05/22/2026; 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: TOTAL PARENTERAL NUTRITION (TPN) INFUSION
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown