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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD CASSETTE RESERVOIRS

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ST PAUL CADD CASSETTE RESERVOIRS Back to Search Results
Model Number 21-7302-24
Device Problem Fluid Leak (1250)
Patient Problem No Information (3190)
Event Date 02/01/2021
Event Type  malfunction  
Event Description
Information received a smiths medical ambulatory infusion pumps|cadd cassette reservoirs - flow stop malfunctioned. The report indicated leaking was occurring on the top where the little blue thing piece is. No patient adverse events reported.
 
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Brand NameCADD
Type of DeviceCASSETTE RESERVOIRS
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 Key11399523
MDR Text Key234282545
Report Number3012307300-2021-01662
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/12/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/02/2021
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 Number4046848
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/26/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/05/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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