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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Failure to Infuse (2340)
Patient Problem Insufficient Information (4580)
Event Date 12/20/2021
Event Type  malfunction  
Event Description
Information was received indicating that a pump with a cadd administration set line attached was not recognizing a new cassette. It was reported the event occurred after successfully infusing hydromorphone and saline over the previous three days with a different cassette attached to the pump. Per the care manager the filling hose of the cassette looked different.
 
Manufacturer Narrative
(b)(6).
 
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Brand NameCADD ADMINISTRATION SET WITH FLOW STOP, MEDICATION
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13265762
MDR Text Key284802392
Report Number3012307300-2022-00816
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeGM
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
Report Date 01/17/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/17/2022
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 Number4158804
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received12/20/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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