MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK/DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2R8480

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

Iv tubing was leaking underneath the drip chamber.The iv pump was alarming air in line when there were no obvious air bubbles, there could have been some air being sucked in from the puncture site/area of leakage.If it was not caught the patient would have not gotten full dose of antibiotic.

• Brand Name: CLEARLINK/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15347193
• MDR Text Key: 299152549
• Report Number: 15347193
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2022,08/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2R8480
• Device Catalogue Number: 2R8480
• Device Lot Number: (10) R921D12085
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1