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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR
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SMITHS MEDICAL ASD, INC. CADD; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7609-24
Device Problems Device Alarm System (1012); Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Information (3190)
Event Date 11/04/2020
Event Type  malfunction  
Event Description
Information was received indicating that immediately on use of a smiths medical cadd cassette reservoir, yellow passage (nrfit) (lumen) at 250ml-cassette was noted to be too thin.It was also noted that after connection with the extension and start of the pump, it showed overpressure on the screen of the pump.No adverse effects were reported.
 
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Brand Name
CADD
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10943004
MDR Text Key219487024
Report Number3012307300-2020-12066
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586044014
UDI-Public10610586044014
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
K162219
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 12/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator No Information
Device Model Number21-7609-24
Device Catalogue Number21-7609-24
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received11/04/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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