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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-2120-0103-14
Device Problem Failure to Infuse (2340)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/29/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical administration set had blood in the tube and the pump did not deliver anything but the pump was also not alarming. Health professionals closed the clamp and pump and switched to a different administration set and the pump worked as usual. Total parental nutrition was being infused at the time. There were no reported adverse events.
 
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Brand NameCADD ADMINISTRATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11375266
MDR Text Key233439608
Report Number3012307300-2021-01530
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSW
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-2120-0103-14
Device Lot Number3873556
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/03/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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