MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS; PUMP, INFUSION

Model Number 8110

Device Problem Pumping Problem (3016)

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

The syringe pump alarmed for channel error and stopped working.This pump was delivering epinephrine.As a result of the pump stopping and the nurse quickly changing the pump out for a replacement, the patient's heart rate and blood pressure increased significantly and require increased monitoring.The error code 356.6710.0 for digital sensors illegal state was registered in the pump's error logs.

• Brand Name: ALARIS
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 13522926
• MDR Text Key: 285554177
• Report Number: 13522926
• Device Sequence Number: 1
• Product Code: FRN
• 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: 11/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8110
• 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: 11/12/2021
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 330 DA
• Patient Sex: Male