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

Model Number	2C7461
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient's chemotherapy would not infuse when attached to patient's primary line.Attempts to troubleshoot were completed to no avail.Set-up verified as correct.New bag was prepared which infused without issue.No harm to patient.

• Brand Name: CLEARLINK
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16918731
• Report Number: 16918731
• Device Sequence Number: 6930755
• Product Code: FPA
• UDI-Device Identifier: 00085412049069
• UDI-Public: (01)00085412049069
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 04/18/2023
• Report Date (Section F): 04/18/2023

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: Health Professional
• Device Model Number: 2C7461
• Device Catalogue Number: 2C7461
• Device Lot Number: SR22J04012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2023
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 75 KG
• Date Report Sent to FDA: 04/18/2023