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U.S. Department of Health and Human Services

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

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ST PAUL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Device Alarm System (1012)
Patient Problems Headache (1880); Nausea (1970)
Event Date 05/24/2021
Event Type  Injury  
Event Description
Information was received indicating that while in use of a smiths medical cadd cassette reservoir, a no disposable, clamp tubing alarm was noted. It was also reported that the patient complained of headache, nausea, and stomachache. Subsequently, the cassette was changed, and alarm was cleared. No further adverse effects were reported.
 
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Brand NameCADD
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
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
akasaka, minato-ku, tokyo
minneapolis, MN 55442
MDR Report Key12084163
MDR Text Key258902409
Report Number3012307300-2021-06628
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 06/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4063420
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 Received05/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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