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

Model Number 1400

Device Problems Computer Software Problem (1112); Unintended Electrical Shock (4018)

Patient Problem Electric Shock (2554)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd duodopa pump had a different lock level then what the patient expected.The patient went to see a neurologist who fiddled with the pump and stated that everything looks fine.Afterwards, the patient discovered that the lock level was at 0 instead of one.The patient was transferred to a specialty pharmacy and they performed troubleshooting on the pump.They stated that the lock level would not change the functionality but they did set the lock level back to 1.Additionally, seven days after the date of the event it was indicated that the patient experienced an electric shock feeling from the pump.There were no reported adverse patient effects.

• Brand Name: CADD DUODOPA PUMP
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9124362
• MDR Text Key: 160213254
• Report Number: 3012307300-2019-04908
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• PMA/PMN Number: N203952
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1401-01
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 45