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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 Excess Flow or Over-Infusion (1311); Inaccurate Delivery (2339)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump was delivering inconsistently.It was reported that, per the nursing staff, the level of gel remaining in the cassettes at the end of the day was not always the same; sometimes more than others.Per reporter the pump was changed and no additional information was available.No adverse patient effects were reported.
 
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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
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11664081
MDR Text Key245353938
Report Number3012307300-2021-03103
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 04/14/2021
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 Number1400
Device Catalogue Number21-1400-06
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/16/2021
Initial Date FDA Received04/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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