MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; MEDICATION CASSETTE RESERVOIR

Lot Number 3607941

Device Problems Device Alarm System (1012); Material Deformation (2976)

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

Event Type  malfunction  

Event Description

Mixed 2 cadd cassettes 100ml w/flow stop.Lot 3607941, and when attempted to prime tubing for use, the cassettes caused both pumps to alarm hgh pressure.Found that the tubing across the top of these cassettes was raised up and not flat.Same with lot 3635421 and lot 3617362.All have raised tubing on top of cassette; 2 cassettes mixed, unusable.

• Brand Name: CADD
• Type of Device: MEDICATION CASSETTE RESERVOIR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8014459
• MDR Text Key: 125601001
• Report Number: MW5080886
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/09/2018
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3607941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1