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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem False Alarm (1013)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2022
Event Type  malfunction  
Event Description
Information was received indicating that during use of the cassette, the pump exhibited a "no disposable, clamp tubing" alarm.No adverse patient effects were reported.Per reporter no further information is available.
 
Manufacturer Narrative
Additional contact information: (b)(6).
 
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Brand Name
CADD MEDICATION CASSETTE
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 Key14149266
MDR Text Key289602588
Report Number3012307300-2022-06666
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number21-7302-24
Device Catalogue Number21-7302-24
Device Lot Number4219994
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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