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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; WARMER, THERMAL, INFUSION FLUID
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SMITHS MEDICAL ASD, INC. CADD; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number 21-7349-24
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
It was reported that smiths medical tubing does not flow.Pump reportedly works fine but no fluid drains from the bag.Nurses and anesthesia troubleshoot and attempted to run the fluid but nothing comes out.They changed the tubing and everything worked fine.No adverse patient effects were reported.
 
Manufacturer Narrative
Device evaluation- two device samples were returned for evaluation.Visual inspection of the devices showed no abnormalities.The devices were connected to cadd-legacy infusion pumps and given functional testing.The devices were found to allow for priming but some resistance occurred at the free flow stop device.Examination at this area showed the devices were returned to smiths medical without the blue clips and kinking at this area of the tube was the cause of the resistance.The blue clips are required to remain on the tubing until connected with pump.The devices could not be further tested due to their returned condition.
 
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Brand Name
CADD
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11086923
MDR Text Key224043305
Report Number3012307300-2020-12794
Device Sequence Number1
Product Code FPA
UDI-Device Identifier15019517184235
UDI-Public15019517184235
Combination Product (y/n)N
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 03/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number21-7349-24
Device Catalogue Number21-7349-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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