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

Model Number MP5303-C

Device Problems Failure to Prime (1492); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2023

Event Type  malfunction  

Event Description

Late 60¿s male with history of hypertension, type 2 diabetes and admitted for change in mental status.Procedure: iv medication-infusion.Bd extension set would not prime when connected to 10ml ns flush- pressure increased without success.Another set was used without problems.2nd time this has occurred with this product, the 1st time was not reported and product was not saved.Manufacturer response for set, administration, intravascular, maxplus (per site reporter).Will obtain.

• Brand Name: MAXPLUS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16378294
• MDR Text Key: 309562118
• Report Number: 16378294
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403236655
• UDI-Public: (01)10885403236655(10)22089430(17)20270823
• 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: 01/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MP5303-C
• Device Catalogue Number: MP5303-C
• Device Lot Number: 22089430
• 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: 01/31/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25185 DA
• Patient Sex: Male
• Patient Weight: 55 KG