MAUDE Adverse Event Report: SMITHS MEDICAL ASD CADD LEGACY CASSETTES; SET, I. V. FLUID TRANSFER

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Pt's spouse reported they have had a problem with the cadd legacy cassettes.The fold in the bottom of the cassette makes it difficult to remove the large air bubbles.Reviewed procedure for filling cassette and they are doing process correctly.Offered to have cnss nurses go out to see if they could help make process easier for pt/spouse.Spouse refused.No other info available.Did not result in adverse event.No interruptions in therapy.Sending replacement cassettes.No lot numbers available.Dates of use: from (b)(6) 2017 to ongoing.

• Brand Name: CADD LEGACY CASSETTES
• Type of Device: SET, I. V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD
• MDR Report Key: 7052207
• MDR Text Key: 92854481
• Report Number: MW5073505
• Device Sequence Number: 1
• Product Code: LHI
• 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: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• 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