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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. CADD-LEGACY® PCA PUMP; PUMP, INFUSION, ENTERAL
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SMITHS MEDICAL ASD; INC. CADD-LEGACY® PCA PUMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 1400
Device Problem Battery Problem (2885)
Patient Problem Pressure Sores (2326)
Event Type  malfunction  
Event Description
Information was received indicating that the battery door to a smiths medical cadd-legacy® duodopa pump was unable to be removed.The patient's spouse noted that the battery may have exploded inside the pump and that it will not power on.The patient was reported to be currently in the hospital for back sore healed.Was noted not to be related to the pump.There were no reported adverse effects.
 
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Brand Name
CADD-LEGACY® PCA PUMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis, MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
1265 grey fox rd
st. paul, MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis,, MN 55442
7633833310
MDR Report Key7695516
MDR Text Key114284824
Report Number3012307300-2018-02846
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 distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/17/2018
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 Lay User/Patient
Device Model Number1400
Device Catalogue Number21-1401-01
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/20/2018
Initial Date FDA Received07/17/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/18/2015
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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