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

Model Number 8100

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem Respiratory Failure (2484)

Event Date 03/31/2021

Event Type  malfunction  

Event Description

During the closing count of a cabg x2 (coronary artery bypass graft) with an impella device in place, and the patient receiving pressors and cardiac drips (vital signs stable), during a minor pump adjustment, the pump began to alarm showing an error reading (error reading was not provided), and shutting down two of the three pressor drips.It took approximately 2-3 minutes to restore the drips because the modules would not attach to the brain.During that time, the mean arterial pressure (map) dropped from 70 to 30.The impella stopped functioning.Resuscitation efforts began, and the patient's vital signs restored to pre-event levels.The impella began to function within 10 minutes.Equipment was not replaced per anesthesiologist due to the complexity of the drug regimen.At this time, the patient remains critically ill and ventilator dependent due to respiratory failure.Other medical issues include pulmonary hypertension, morbid obesity, dm (diabetes mellitus), pvd (peripheral vascular disease), and copd (chronic obstructive pulmonary disease).The pump was inspected by our biomed manager.The infusion pump main brain and pump modules inter-unit interface connectors on the side of these devices need to be verified/ checked and cleaned, as needed, by individuals responsible for cleaning and setting up the pumps.This will significantly reduce or eliminate the issue of modules disconnecting.

• 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: 11731680
• MDR Text Key: 247507294
• Report Number: 11731680
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 04/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2021
• 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: 23360 DA
• Patient Weight: 143