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

Model Number 8015

Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem: Medication Error (3198)

Patient Problem Overdose (1988)

Event Date 12/28/2020

Event Type  malfunction  

Event Description

Patient had a 250 ml bag of heparin infusion via pump.The pump was started and programmed at 10.6ml/hour at 1342.At 1452 the pump shut off and it was noted the whole bag (250mls) had infused.

• 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: 11332333
• MDR Text Key: 231992703
• Report Number: 11332333
• 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: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8015
• 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: 01/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14600 DA