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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD EXTENSION SET

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ST PAUL CADD EXTENSION SET Back to Search Results
Device Problems Device Alarm System (1012); Contamination (1120)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
Information received a smiths medical admin set could not be flushed by the pump. An "upstream occlusion" alarm occurred during the infusion. Kins were visible in the tubing. No patient injury was reported.
 
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Brand NameCADD
Type of DeviceEXTENSION SET
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11776267
MDR Text Key249011067
Report Number3012307300-2021-03818
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 05/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/10/2020
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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