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

Model Number 2C8541

Device Problems Disconnection (1171); Material Split, Cut or Torn (4008)

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

Event Date 12/29/2022

Event Type  malfunction  

Event Description

Patient receiving melphalan chemotherapy day-1 auto stem cell transplant.Patient informed covering rn of feeling "wetness" on clothing shortly after chemotherapy began (approximately 2 minutes).Covering rn stopped chemo infusion immediately.Tubing inspected and was found to have completely split in half and disconnected at y-site.Chemotherapy disconnected from patient's central line.Patient took off clothing and washed thigh with soap and water.No chemotherapy anywhere beside patient clothing, skin intact with no abnormalities.Covering provider and pharmacy notified.Pharmacy made new chemotherapy bag.Manufacturer response for iv tubing, iv tubing (per site reporter) ongoing issue with baxter tubing.

• Brand Name: CLEARLINK/CONTINU-FLO/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16193892
• MDR Text Key: 307571369
• Report Number: 16193892
• 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: 01/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C8541
• Device Catalogue Number: 2C8541
• Device Lot Number: R22108024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1