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

Model Number	2R8519
Medical Device Problem Codes	Volume Accuracy Problem (1675); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported there were flow rate accuracy issues while using an unspecified quantity of clearlink non-dehp continu-flo solution sets.The flow rate inaccuracies were observed when running at a maximum rate of 1200 ml/hr; there was significant residual fluid in the bags.This was identified during patient infusions in the intensive care unit (icu).The residual was noticed with primary or secondary infusions on different pumps, different users, and different medications.This event would often be noticed following lengthy infusions running at keep vein open (kvo) 10 ml/hr followed by a flow rate increase to 1200 ml/hr (other times using the bolus key).The tubing in all cases were loaded correctly and were observed to have significant kinks at where the pinch clamps occlude the line within the pumping mechanism.They also reported that by reposing the tubing before increasing the rate (or after bolus complete) resulted in significantly improved accuracy.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h6.H11: the device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK/CONTINU-FLO
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; 600 mts oeste de entrada; las americas parque industrial; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22018861
• Report Number: 1416980-2025-02829
• Device Sequence Number: 9411796
• Product Code: FPA
• UDI-Device Identifier: 00085412565682
• UDI-Public: (01)00085412565682
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K180739
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2R8519
• Device Catalogue Number: 2R8519
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: NOVUM IQ LVP; UNSPECIFIED MEDICATION
• Patient Sex: Unknown