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

Device Problem Fail-Safe Did Not Operate (4046)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

When rn was removing the tubing from the iv pump, the safety mechanism as designed failed to engage.

• Brand Name: ALARIS INFUSION TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 15275312
• MDR Text Key: 298403589
• Report Number: 15275312
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/23/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Sex: Male
• Patient Weight: 91 KG