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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD-LEGACY 1400 PUMP; PUMP, INFUSION, ENTERAL PRODUCT CODE: LZH
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SMITHS MEDICAL ASD, INC. CADD-LEGACY 1400 PUMP; PUMP, INFUSION, ENTERAL PRODUCT CODE: LZH Back to Search Results
Catalog Number 21-1400-51
Device Problems Device Alarm System (1012); Infusion or Flow Problem (2964)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported that a patient had issues with a smiths medical cadd-legacy 1400 pump at home as alarms kept going off.Patient experienced cramps daily.An x-ray showed that the tube wasn't going directly into her duodenum.Doctors notified her that she was taking 7-8 extra doses a day.The tube was split and she had nearly 5cm cut off the tube.Patient said everything has been better since exchanging the tube.Duodopa has relieved her anxiety but she still gets tremors here and there." no further adverse patient effects were reported.
 
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Brand Name
CADD-LEGACY 1400 PUMP
Type of Device
PUMP, INFUSION, ENTERAL PRODUCT CODE: LZH
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
dave halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key9604888
MDR Text Key175847703
Report Number3012307300-2020-00496
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 health professional,user faci
Reporter Occupation Other
Type of Report Initial
Report Date 01/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue Number21-1400-51
Was Device Available for Evaluation? No
Date Manufacturer Received12/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/21/2017
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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