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 Nausea (1970); Dyskinesia (2363); No Information (3190)

Event Date 11/21/2020

Event Type  malfunction  

Event Description

Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion day pump remained connected during the night instead of the night pump.It was reported that the continuous dose on the day pump was 1.4 ml more than the night pump.Per reporter, the nurse was advised to keep the day pump on, not administer the morning dose and use the extra dose if necessary.It was also reported that the patient had hidden the night pump, was very suspicious, was not allowing the cassette to be replaced or the pump dosages to be adjusted.

Manufacturer Narrative

Other, other text: additional information was received indicating that the night pump disappeared and when it was found it was reconnected at night.Subsequently; the patient did not want the night pump connected because she was convinced it was a bomb and the day pump stayed connected during the night.Patient was not amenable and was confused in such a way that she wanted to rip the pegj out of her abdomen.Care could not approach the patient because she was making bite-movements programmed settings on day pump: morning dose 4.0, continuous dose 5.6 (before adjusted by duodopa specialist( extra dose 4.1 (lock of 4 hours) lock out level 0; patient experienced nausea and dyskinesia.No medical intervention given because of patient's behavior; a urinary tract infection was diagnosed and nr antibiotic was started; patient reported to have increased in suspiciousness, confusion and hallucinations.Patient has some clear moments, but is still in psychosis.Patient does not always take medication for treatment of psychosis due to suspiciousness, she hides medication.

• 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: 10984287
• MDR Text Key: 220693299
• Report Number: 3012307300-2020-12268
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1400
• Device Catalogue Number: 21-1400-06
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/10/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 74 YR