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U.S. Department of Health and Human Services

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

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ST PAUL CADD ADMINISTRATION SET WITH FLOW STOP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problem Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/30/2022
Event Type  malfunction  
Event Description
It was reported that when the customer attached the medical fluid-filled cassette to the pump during the pre-use check, an alarm went off. There was no patient injury.
 
Manufacturer Narrative
Device evaluation: the device was returned for analysis. Investigation including root cause analysis is in progress. A supplemental mdr will be filed as necessary in accordance with 21 cfr 803. 56 when additional reportable information becomes available.
 
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Brand NameCADD ADMINISTRATION SET WITH FLOW STOP
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
7-15-26 fukushim
minneapolis, MN 55442
MDR Report Key15045811
MDR Text Key304038685
Report Number3012307300-2022-13533
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10610586027239
UDI-Public10610586027239
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 07/18/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2022
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 Number4235250
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2022
Was the Report Sent to FDA? No
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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