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 Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Event Description

Information was received indicating that patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump did not have a night pump and was using the day pump, keeping the same dosages, during the night per reporter patient indicated the need to use pump "when going to the toilet." it was reported that levodopa/carbidopa retard tablets were not longer being used.Per reporter the extra dose was lowered to 4.0ml, patient was using no morning dose and it was suspected that the patient "regularly adjusts his continuous dose." it was reported that the morning dose was set to 0.0 ml, the extra dose to 2.5 ml and had previously been 4.9 ml and was decreased to 4.0 ml.Per reporter pump now has a lock level of 2 so the patient is no longer able to change the pump values.It was also reported that it was "unclear if the cassettes are very low, because patient doesn't change them or that patient uses the extra dose too much.Advised care to change the cassettes twice a day." no adverse patient effects were reported.

Manufacturer Narrative

Other, other text: additional information was received indicating patient details (updated a2, a3), no known patient injury (updated h6), other relevant history (updated b7).

• 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: 11599734
• MDR Text Key: 243327821
• Report Number: 3012307300-2021-02732
• 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: 04/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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: 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR