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

Model Number 1400

Device Problem Use of Device Problem (1670)

Patient Problem Ambulation Difficulties (2544)

Event Date 10/11/2020

Event Type  malfunction  

Event Description

Information was received indicating that the morning dose on a smiths medical cadd-legacy duodopa ambulatory infusion pump was too high.It was reported that "the lock level 2 was set up to ensure that no change will be made anymore by the patient." per reporter patient felt blocked (not able to move).It was also reported that the pump alarmed "volume not usable.".

Manufacturer Narrative

Additional information was received indicating, concomitant drug, levodopa - benserazide (prolopa hbs) for parkinson's disease treatment: nitro furantoine (furadantine) for urinary tract infection.Duodopa overdose non-serious and recovered no laboratory test in the medical history.

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 the entire device was worn, the front and rear housing were scratched and the lock was worn.Review of the event history log showed that the device was never set on lock level two.The investigation found that the pump did not display any errors on power up or in the error log.There were no reports of any unusual messages found in the event history log.The pump passed all tests and was found to be operating properly.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: 10765611
• MDR Text Key: 214080945
• Report Number: 3012307300-2020-10856
• 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,Followup
• Report Date: 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2020
• 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: 21-1400-06
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR