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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
Device Problem Device Alarm System (1012)
Patient Problem Anxiety (2328)
Event Date 01/11/2022
Event Type  malfunction  
Manufacturer Narrative
No lot number was provided; therefore, device history record review could not be completed.No product sample was received; therefore, visual, and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.Udi and catalog number, initial reporter sent report to fda, and 510k are unknown.No information has been provided to date.
 
Event Description
It was reported that during use of the device, a no disposable alarm occurred.A new cassette was used to restart the remodulin infusion.The patient was anxious and panicky due to the no disposable alarm.No additional information is available.No patient injury was reported.
 
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Brand Name
CADD
Type of Device
SET, 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
jim vegel
6000 nathan lane north
suite 100
minneapolis, MN 55442
MDR Report Key15319248
MDR Text Key305382962
Report Number3012307300-2022-05343
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/02/2022
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
Patient Sequence Number1
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