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

Model Number 8100

Device Problems Defective Device (2588); Difficult to Open or Close (2921)

Patient Problem Insufficient Information (4580)

Event Date 11/19/2021

Event Type  malfunction  

Event Description

A full bag of heparin infused within 2.5 hours.Channel of pump not functioning properly.Even after channel door closed - clamp not working and iv tubing did not clamp.The door latch pin is sticking out and making the door difficult to close and latch because it is hitting the other pump.Fda safety report id # (b)(4).

• Brand Name: BD/ALARIS/CAREFUSION PUMP
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): BD / CAREFUSION 303, INC.
• MDR Report Key: 12934151
• MDR Text Key: 281911360
• Report Number: MW5105806
• Device Sequence Number: 1
• Product Code: FRN
• 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: 12/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 8100
• Device Catalogue Number: 600889102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American