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

Model Number 2C8419

Device Problem Material Puncture/Hole (1504)

Patient Problems Arrhythmia (1721); Low Blood Pressure/ Hypotension (1914); Lethargy (2560); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/21/2022

Event Type  Injury  

Event Description

Situation: patient experienced pea (pulseless electrical activity) arrest following hypotension.Iv line for iv pressors was found to have a hole in it.Background: patient was on 7-5 when he became lethargic and hypotensive, rrt was called and levophed was started on 7-5.Patient came to the micu at 23:24.Micu rn noticed blood back up into tubing, rn flushed site without issue and hooked back up iv.At 23:40, while settling patient during assessment turn, patient noted to be agonal and rn unable to feel a pulse, so compressions initiated, and patient intubated.Rosc (delayed return of spontaneous circulation) achieved at 23:45.To note, rn changed out levophed line during code due to blood back up dripping onto floor.Assessment: old levophed tubing was assessed by flowing ns through it and a large hole noted at upper portion of tubing.Tubing sequestered and picture taken.Recommendation: follow up online malfunction.Manufacturer response for iv tubing, primary iv administration set clearlink¿ 10 drops / ml drip rate 92 inch tubing 1 port (per site reporter) baxter notified, rma requested.Pr (b)(4).

• Brand Name: CLEARLINK/DUO-VENT
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 15713784
• MDR Text Key: 302835931
• Report Number: 15713784
• 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: 10/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2C8419
• Device Catalogue Number: 2C8419
• 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: 10/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/02/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening