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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD ADMIN SETS SET, ADMINISTRATION, INTRAVASCULAR

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ST PAUL CADD ADMIN SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problems Device Alarm System (1012); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Operator of device: patient/consumer. No additional information has been received to date. No product has been returned to date. 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.
 
Event Description
It was reported that, during priming with a new cassette, the pump was alarming high pressure, which may have been due to a kink in the fluid path. The tubing was changed out, the issue resolved, and infusion continued. No patient injury was reported.
 
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Brand NameCADD ADMIN SETS
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
105 mall blvd
minneapolis, MN 55442
MDR Report Key14973651
MDR Text Key303952818
Report Number3012307300-2022-13183
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation
Type of Report Initial
Report Date 07/09/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/16/2022
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

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