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

Model Number 1400

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Ambulation Difficulties (2544)

Event Date 07/23/2020

Event Type  malfunction  

Event Description

Information was received indicating that a patient who had just received a new smiths medical cadd-legacy duodopa ambulatory infusion pump accidentally used the old pump to administer a morning dose and then subsequently put on the new pump and administered a second morning dose.Per reporter the programmed morning dose for the patient was 17ml.Reported indicated that the pump was programmed correctly.It was reported that patient could not walk.It was reported that patient stated he was well at the time of reporting the incident the following day.

• Brand Name: CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP
• Type of Device: PUMP, INFUSION, ENTERAL,
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.,; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north,; minneapolis, mn
• Manufacturer Contact: david halverson ; 6000 nathan lane north,; minneapolis, mn
• MDR Report Key: 10469592
• MDR Text Key: 204859861
• Report Number: 3012307300-2020-06906
• 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: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2020
• 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: 21-1400-08
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 76 YR