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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 21-7324-01
Device Problem Infusion or Flow Problem (2964)
Patient Problem Pain (1994)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
The lot number is unknown at this time.
 
Event Description
Information was received indicating that at the end of therapy with a smiths medical cadd administration set, it was noted that it did not deliver any medication. It was also reported that the patient experienced pain despite pressing the button of remote three times. No further adverse 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
parc euromedecine
minneapolis, MN 55442
MDR Report Key12274257
MDR Text Key264962409
Report Number3012307300-2021-08037
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial
Report Date 08/04/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7324-01
Device Catalogue Number21-7324-24
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 Received07/05/2021
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

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