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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD LEGACY 1 PUMP; PUMP, INFUSION
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SMITHS MEDICAL ASD, INC. CADD LEGACY 1 PUMP; PUMP, INFUSION Back to Search Results
Model Number 6400
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd legacy 1 pump failed accuracy by +14.15%.There was no reported adverse event.
 
Manufacturer Narrative
Additional information received on 13-mar-2020 that the issues occurred during testing.Device evaluation: one cadd legacy pump was returned for analysis.Visual inspection performed, and product found to be in condition with scratched screen.Event history log review was performed and found evidence of reported problem.According to the investigation, the customer's reported problem regarding delivery accuracy was able to be duplicated.The investigation reported that three separate delivery accuracy tests were performed and at least one test was found outside of the pump's delivery accuracy manufacturing specification.According to the investigation, the pump expulsor will be replaced to bring delivery accuracy into specification.The problem source of the reported problem is unknown.
 
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Brand Name
CADD LEGACY 1 PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9772573
MDR Text Key181536659
Report Number3012307300-2020-01773
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10610586019548
UDI-Public10610586019548
Combination Product (y/n)N
PMA/PMN Number
K982838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor
Type of Report Initial,Followup
Report Date 04/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number6400
Device Catalogue Number21-6400-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2020
Date Manufacturer Received03/02/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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