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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP; PUMP, INFUSION, ENTERAL
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SMITHS MEDICAL ASD, INC. CADD-LEGACY DUODOPA AMBULATORY INFUSION PUMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 1400
Device Problem Use of Device Problem (1670)
Patient Problem Ambulation Difficulties (2544)
Event Type  malfunction  
Event Description
Information was received indicating that a patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump changed doses on the pump due to no lock level on the pump.It was reported that the patient reported being "unable to move/turn in bed overnight, reports feeling off most of the night and unable to get to sleep until early morning." per reporter the night pump's continuous rate was programmed to 2.1 ml/hr and that the patient subsequently reported that the continuous rate was 2.5ml/hr.Per reporter patient's doctor indicated "he is happy to go as high as 2.5 ml/hr if no improvement with the removal of sinamet plus.
 
Manufacturer Narrative
Additional information was received indicating the reported issue did not cause or contribute to patient injury and that the issue is ongoing.Patient information was received.
 
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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 Key10955589
MDR Text Key219887687
Report Number3012307300-2020-12176
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 12/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1400
Device Catalogue Number21-1400-51
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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