MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1C8043

Device Problem Chemical Spillage (2894)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2018

Event Type  malfunction  

Event Description

Patient receiving chemotherapy infusion of taxol.Taxol infusion finished.Stopped the pump and went to administer next chemotherapy agent of carboplatin.After hanging the medication.I slipped on something wet on the floor.Originally i thought it was water so i picked up the large liquid spill with a chux pad.Then i could smell a chemical smell.At this time the patient went to go to the bathroom, and she was wet all over the right side of her pant, and jackets.The taxol had leaked on the patient, and on the floor.Appears to be something wrong with the tubing, causing the chemotherapy spill.

• Brand Name: DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 25212 w. illinois route 120; round lake IL 60073
• MDR Report Key: 7613311
• MDR Text Key: 111486319
• Report Number: 7613311
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412019994
• UDI-Public: (01)00085412019994
• 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: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1C8043
• Device Catalogue Number: 1C8043
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY