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

Model Number 1400

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Dyskinesia (2363)

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump may have over-delivered medication.Per reporter the patient reported that a "cartridge that usually lasts for 48 hours" was almost used in the first 24 hours.It was reported that the patient "claims not to have modified the pump." it was reported that patient was experiencing dyskinesias.It was reported that a new pump was subsequently to be provided to the patient.Reported pump programming: "dm:8.8 tc:2.60 de: 3.00 dm lock 14 hours, 1-hour lock.".

Manufacturer Narrative

Additional information was received indicating that the pump serial number was reported incorrectly.Device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed the that the lcd had missing pixels and the bolus connector on the rear housing was broken.The pump was tested and was found to be functioning properly and delivering within specifications.The reported issue could not be duplicated.Based on the investigation, the complaint allegation was not confirmed.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 11015463
• MDR Text Key: 221730919
• Report Number: 3012307300-2020-12441
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 01/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1