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

Model Number 2426-0500

Device Problem Gas/Air Leak (2946)

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

Event Date 02/13/2019

Event Type  malfunction  

Event Description

Patient's nurse noticed an unusual "bubble" in the iv tubing from a bd alaris pump infusion set with back check valve - ref # (b)(4).The bubble was noticed when the nurse unloaded the iv tubing from the alaris carefusion infusion pump.The "bubble" is in the portion of the tubing that goes into the peristaltic portion of the infusion pump.No pump alarms sounded.The "bubble" is 2 cm long and 1.5 cm in diameter.As far as the nurse could tell the bubble in the tubing did not interfere with the operation of the pump or the delivery of the medicine.Unfortunately the tubing package was not available to get the lot number.Based on the lot numbers of the extra packages in the patient's nurse-server care it is possible that the unusual tubing was from one of these three lot numbers: (10) 18113112, (10)181113126 or (10)18116462.The iv pump serial number was not recorded.It remains in use within the facility.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 8353488
• MDR Text Key: 136602817
• Report Number: 8353488
• 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: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2019
• Date Report to Manufacturer: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27375 DA