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

Catalog Number 2C8419

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Lethargy (2560)

Event Date 09/21/2022

Event Type  Injury  

Event Description

It was reported that during a patient intravenous (iv) infusion of ¿7-5¿ with a clearlink system solution set, the patient experienced pulseless electrical activity arrest.The nurse reported during iv infusion the patient became lethargic and hypotensive.The rapid response team was called, and "levophed was started on 7-5".Backflow of blood in the tubing was observed so the site was flushed, and no issues were noted.Sixteen minutes later, the patient was noted to be agonal, and the nurse was reportedly "unable to feel a pulse so compressions were initiated, and the patient was intubated".Five minutes later, return of spontaneous circulation was achieved.The nurse changed the set ¿due to blood back up dripping onto floor¿ and a large hole was noted at upper portion of tubing.No additional information is available.

Manufacturer Narrative

Initial reporter phone no.Cell: (b)(6).The user facility submitted medwatch 0700220000-2022-8283 for this event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device and photographs of the sample were received for evaluation.Visual inspection with the naked eye of the pictures identified a hole in the tubing.Visual inspection with the naked eye of the actual device identified a hole in the tubing.The cut is approximately 80cm away from the drip chamber tube port.The reported condition was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DUO-VENT CLEARLINK LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15661002
• MDR Text Key: 302340992
• Report Number: 1416980-2022-05669
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C8419
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: LEVOPHED.
• Patient Outcome(s): Required Intervention