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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD PUMP, INFUSION

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ST PAUL CADD PUMP, INFUSION Back to Search Results
Model Number 21-7106-24
Device Problem Leak/Splash (1354)
Patient Problem Headache (1880)
Event Date 04/20/2021
Event Type  malfunction  
Event Description
It was reported that a smiths medical admin set had a leak in the air filter. Patient complained of a leak and headache. The set is used for flolan administration, so headaches could be a result of underdosing. No further adverse patient effects were reported.
 
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Brand NameCADD
Type of DevicePUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11869002
MDR Text Key252149013
Report Number3012307300-2021-04868
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7106-24
Device Catalogue Number21-7106-24
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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