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

Model Number 2C8541

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/15/2024

Event Type  Injury  

Event Description

Situation: broken iv tubing.Background: elderly male with history of afib, strokes, high risk mds (myelodysplastic syndromes) admitted with ams (altered mental status), found to have multifocal strokes.Patient was receiving d5 1/2 ns is on a high-risk heparin drip, both infusing through hickman.Assessment: provider walked in to check on patient who was covered in a large amount of blood.Upon further assessment, it was discovered that the iv line for d5 1/2ns was severed between the second and third y-site locations.Part of the line was still connected to the patient and was backflowing blood.The other portion of the line was still going through the pump but not attached to anything.A stat cbc was collected due to blood loss.Recommendation: the product was not retained due to contamination with blood but we will follow up with materials management.Manufacturer response for iv tubing, (brand not provided) (per site reporter).Meeting every other week to review new events since december, and actively meeting since 2021.

• 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: 18928873
• MDR Text Key: 337984396
• Report Number: 18928873
• 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: Nurse
• Type of Report: Initial
• Report Date: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 2C8541
• Device Catalogue Number: 2C8541
• Device Lot Number: NOT KNOWN
• 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: 02/29/2024
• Event Location: Hospital
• Date Report to Manufacturer: 03/19/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention