MAUDE Adverse Event Report: CAREFUSION 303, INC. BD ALARIS PUMP INFUSION SET IV TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2426-0007

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Diminished Pulse Pressure (2606); Respiratory Arrest (4461)

Event Date 10/27/2023

Event Type  Death  

Event Description

Situation: (b)(6) 2023, the rn reported, the patient's mean arterial pressure dropped to 63 and the iv pump with levophed infusing at 80 mcg/min was beeping with a "check channel" error twice.Al this time, levophed was titrated up.The rn tried to transfer levophed tubing to a different channel and found levophed tubing was leaking.Neo was given per md at the bedside.Pt map rapidly dropped to 48, new tubing restarted, at this lime levophed infusing at 200 mcg/min per md order.The patient became pulseless and cpr was started.The iv tubing was found to have a small hole in ii.During the transfer of the lines, the pt was only supported by neo.Given the brittle and fragile pt, she was unable to tolerate this and coded.She was brought back quickly but was too unstable and coded again.After the 3rd code, the family withdrew care." patient expired on the same day as the event, (b)(6) 2023.

• Brand Name: BD ALARIS PUMP INFUSION SET IV TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121 4386
• MDR Report Key: 18159432
• MDR Text Key: 328609806
• Report Number: MW5148238
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2426-0007
• Device Lot Number: (10)23089161
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American