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

Model Number MX9060

Device Problems Partial Blockage (1065); Failure to Prime (1492)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2017

Event Type  malfunction  

Event Description

The iv extension tubing was discovered to be blocked when kit lines would not prime.The device was not connected to any patient.We had four separate lines that did the same thing.All extension tubing sets were from the same lot.

• 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: 6964952
• MDR Text Key: 89859274
• Report Number: 6964952
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2017
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: MX9060
• Device Catalogue Number: MX9060
• Device Lot Number: 17045256
• Other Device ID Number: M609MX90600J
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/09/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1