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 Dyskinesia (2363)

Event Type  Injury  

Event Description

Information was received indicating that a patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump received an overdose of duodopa.It was reported that the patient was suspected of adjusting the pump rates.Per reporter, the pump was on lock level one and was programmed to an upper limit of 2.2ml; however, the pump could still be manually set higher and it was found that the continuous dose was set on 3.7 ml/hour.Per reporter the dose was subsequently changed to 2.2 ml/hour.It was reported that the patient experienced severe dyskinesia and was hospitalized as a precaution and no further medical intervention was planned.It was reported that the pump was "stopped, as usual for the night.The next day was started up again at the correct dosage." it was also reported that the patient had a "very small therapeutic window for l-dopa.".

Manufacturer Narrative

Other, other text: device evaluation: one smiths medical cadd-legacy duodopa ambulatory infusion pump was returned for analysis in used condition.Visual inspection showed no physical damage on the pump.The reported error message lec 1816 was not found at power up or in the event history log.In addition the event history log showed numerous changings of the "delivery rate," on (b)(6) 2020 the highest rate concerning the "morning dose" was 3,0 ml/h and highest rate concerning "continuous dose" was 2.1 ml/h in contrast to the reported "continuous dosage was set on 3.7ml/h." the pump was found to be operating properly and passed all tests.Based on the investigation, the complaint allegation was not confirmed.

• 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 55442
• MDR Report Key: 10477046
• MDR Text Key: 205121667
• Report Number: 3012307300-2020-08879
• 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: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization