MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; CADD PUMP, INFUSION

Model Number	2120
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came into the cancer center for disconnection of d2 epoch (chemo regimen) and reconnection with d3 epoch via cadd pump.When patient arrived they reported that during the night they discovered the cadd pump was not infusing the chemo.They called the 800 number on the pump and the center's on call/sick after hours line.They were instructed to do several things but could not get the pump running.They were instructed to come to the clinic in the morning.When they arrived the pump was on, blinking green but the bag appeared full.The counter on the pump showed 500cc to be infused (the wife reports that she cleared the volume infused while trying to get it running again per the support staff).

• Brand Name: CADD
• Common Device Name: CADD PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11504693
• Report Number: 11504693
• Device Sequence Number: 3843909
• Product Code: FRN
• UDI-Device Identifier: 15019517126617
• UDI-Public: (01)15019517126617
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/26/2021
• Report Date (Section F): 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2120
• Device Catalogue Number: 21-2120-0104-231
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 03/17/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 01/26/2021