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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 Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)
Patient Problem Muscle Spasm(s) (1966)
Event Date 06/16/2020
Event Type  malfunction  
Event Description
Information was received indicating that the "blocking time" on a smiths medical cadd-legacy duodopa ambulatory infusion pump was set to one (1) hour and a patient who was just in the titration phase at the beginning of duodopa therapy at the hospital had administered the morning dose several times.It was reported that the patient was hyperkinetic "since 6 p.M.And the duodopa cassette is already empty." the morning dose was subsequently set to twenty (20) hours and it was advised to pause the pump.No additional adverse effects were reported.
 
Manufacturer Narrative
Other, other text: additional information was received confirming that the cause of the over-dosing of medication was due to incorrect programming of the morning dose lockout time on the pump and the patient repeatedly selecting the morning dose.
 
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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 Key10244584
MDR Text Key197939897
Report Number3012307300-2020-06982
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 08/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model Number1400
Device Catalogue Number21-1400-03
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received07/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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