MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	2R8858
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device manufacturer address (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that an unspecified quantity of underinfusions occurred during the use of clearlink, paclitaxel sets during infusion.It was observed that there were multiple incidents of taxol infusing too slow and running 30 minutes to 1 hour longer than expected.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
B5: additional information was received indicating at least four (4) events occurred on a spectrum iq pump with a flow rate 200-300ml/hr.H4: the lot was manufactured between october 27, 2023 and october 28, 2023.H11: the actual devices were not available; however, three (3) companion samples were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure and clear passage under water testing, and priming were performed on the samples with no issues noted.A simulation run was performed on an in-lab spectrum pump with no issues noted.The reported condition was not verified on the companion samples.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
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19367116
• Report Number: 1416980-2024-02412
• Device Sequence Number: 3727929
• Product Code: FPA
• UDI-Device Identifier: 00085412565774
• UDI-Public: (01)00085412565774(10)R23J26086(17)251020
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K160007
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2024

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 Expiration Date: 10/20/2025
• Device Model Number: 2R8858
• Device Catalogue Number: 2R8858
• Device Lot Number: R23J26086
• 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: 04/29/2024
• Supplement Date Received by Manufacturer: 06/26/2024
• Initial Report FDA Received Date: 05/21/2024
• Supplement Report FDA Received Date: 06/28/2024
• 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: INTRAVENOUS PIGGYBACK BAG; PACLITAXEL; SPECTRUM IQ PUMP
• Patient Sex: Unknown