MAUDE Adverse Event Report: CAREFUSION 303, INC. MAXPLUS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MP5314-C
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Tubing is blocked, no liquid will flow through.

• Brand Name: MAXPLUS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 15742800
• Report Number: 15742800
• Device Sequence Number: 20601521
• Product Code: FPA
• UDI-Device Identifier: 10885403236723
• UDI-Public: (01)10885403236723
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 10/25/2022
• Report Date (Section F): 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MP5314-C
• Device Catalogue Number: MP5314-C
• Device Lot Number: 22069320
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/07/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/07/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 10/25/2022