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

Model Number 2C8851

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 04/10/2018

Event Type  malfunction  

Event Description

Patient had docetaxel infusing via rcw port.Patient alerts this rn that she feels a "wet spot" on her left thigh.Pump was stopped and area assessed.Chemo found to be leaking from taxotere tubing.Chemo disconnected from patient and returned to pharmacy.

• Brand Name: CLEARLINK/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 7453946
• MDR Text Key: 106278272
• Report Number: 7453946
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2C8851
• Device Catalogue Number: 2C8851
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/18/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 04/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY
• Patient Age: 69 YR