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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL, ASD, INC. CADD® CADD-LEGACY® DUODOPA PUMP; PUMP, INFUSION, ENTERAL
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SMITHS MEDICAL, ASD, INC. CADD® CADD-LEGACY® DUODOPA PUMP; PUMP, INFUSION, ENTERAL Back to Search Results
Catalog Number 21-1400-08
Device Problem Device Emits Odor (1425)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It was reported that the patient's relative reported that the cadd® cadd-legacy® duodopa pump had a burnt smell.No report of patient injury.
 
Manufacturer Narrative
One pump was returned for analysis in used condition.Visual inspection found that the pump was in good physical condition.The event history log had no related findings.Functional testing included use testing.The pump was powered up and the burnt smell was unable to be duplicated.Visual inspection of the pump was unable to verify the issue as there were no burn marks or odor.The pump passed function and delivery testing and the alarm sensors were within specification.The pump was opened up and further inspected and no abnormalities were found.Based on the evidence, the complaint was unable to be confirmed.
 
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Brand Name
CADD® CADD-LEGACY® DUODOPA PUMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
SMITHS MEDICAL, ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key7786280
MDR Text Key117270740
Report Number3012307300-2018-03290
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 consumer,distributor,foreign
Type of Report Initial,Followup
Report Date 10/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number21-1400-08
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/31/2018
Date Manufacturer Received09/26/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CARBIDOPA; LEVODOPA
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