MAUDE Adverse Event Report: SMITHS MEDICAL CADD EXTENSION TUBING

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pt still having issues with bubbling in her cadd extension tubing even with a new lot number, a nursing visit will be arranged to ensure that the pt is not doing something to cause the issue.Pt denies any bubbles in the cassette prior to priming the tubing.Pt has had to waste a lot of med as a result.No harm done to pt.No further info is available.Dose or amount: 8ng/kg/min, frequency: continuously, route: infuse.Dates of use: (b)(6) 2017 - current.Diagnosis or reason for use: i27.0.

• Brand Name: CADD EXTENSION TUBING
• Type of Device: CADD EXTENSION TUBING
• Manufacturer (Section D): SMITHS MEDICAL
• MDR Report Key: 6816484
• MDR Text Key: 83676239
• Report Number: MW5071760
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 08/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1