MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10794983

Device Problems Fluid/Blood Leak (1250); Infusion or Flow Problem (2964)

Patient Problem Discomfort (2330)

Event Date 05/25/2021

Event Type  malfunction  

Event Description

Found intravenous (iv) bifuser leaking in patient's bed twice.Changed iv bifuser first time when the bed and iv tubing were found wet, found it to be leaking again about a half hour later.No visible cracking noted.Infant was not receiving ordered fentanyl drip and versed drip because they were leaking into bed.Infant was extremely agitated and thrashing head around.Infant is intubated and was dangerously agitated.

• Brand Name: ALARIS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 11958144
• MDR Text Key: 254856139
• Report Number: 11958144
• 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: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 10794983
• Device Catalogue Number: 10794983
• Device Lot Number: (10)20105151
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 06/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 30 DA