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

Device Problems Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 08/17/2016

Event Type  malfunction  

Event Description

Patient connected to cadd legacy plus pump to infuse 5fu over 46 hours.Does unhook from pump at home and when is scheduled for next cycle, brings pump back into office with empty 5fu bag and port needle/dressing.Approximately 3 weeks later, the patient and wife stated that the pump began beeping around 8 am on the day it was to complete.The expected time of completion was around noon.They stated that there were messages ("a, 0, 1") that made no sense to them.They noticed that the infusion was complete so they did not call for assistance with the pump but rather just turned it off and disconnected it from patient.While the dates do not match up, this is how the event is reported.I believe this was the next scheduled dose.The pump was returned to the rental company.

• Brand Name: CADD LEGACY
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 1265 grey fox rd.; saint paul MN 55112
• MDR Report Key: 6089221
• MDR Text Key: 59515571
• Report Number: 6089221
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/30/2016

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
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2016
• Event Location: Home
• Date Report to Manufacturer: 09/30/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/09/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: CHEMOTHERAPY; NO
• Patient Age: 43 YR