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

Model Number MX5301

Device Problems Product Quality Problem (1506); Improper Flow or Infusion (2954)

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

Event Date 01/23/2023

Event Type  malfunction  

Event Description

We have a new iv extension set on our unit ¿ bd maxguard pressure rated extension set mx5301 (lot 22099253).We have had three nurses complain that it wouldn't bolus the maintenance iv fluid ether on or off the pump.On labor and delivery, we bolus intravenous fluids (ivfs) on most patients and need this to work.One nurse connected her pitocin to the main connection and the lr to the piggyback port in order to have the lr bolus.She labeled her lines well since pitocin is a high risk medication for laboring moms.But we worry that there could be mistakes made if the lr isn't in the "main connection".We are also concerned that we can't trust we can bolus ivf when we need to.Some nurses have not had problems with ivf bolus rates with these extension sets.

• Brand Name: MAXGUARD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 16371236
• MDR Text Key: 309492260
• Report Number: 16371236
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: MX5301
• Device Catalogue Number: MX5301
• Device Lot Number: 22099253
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1