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

Model Number 2123-0007

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/02/2016

Event Type  malfunction  

Event Description

Primary line continually filled with air bubbles even though the system was all connected appropriately (maybe there was a hole?).Both the primary and secondary line were new yesterday and had been primed by me and worked just fine yesterday.Will give whole set up to my charge rn to bring to safety huddle tomorrow.

• Brand Name: ALARIS, VERSASAFE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 6710099
• MDR Text Key: 79945404
• Report Number: 6710099
• 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: 06/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2123-0007
• Device Catalogue Number: 2123-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/30/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR