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U.S. Department of Health and Human Services

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

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ST PAUL CADD SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7308-24
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Phone: (b)(6).
 
Event Description
Information was received indicating that a smiths medical cassette was used and the infusion was not delivered to the patient and did not alarm. When they changed the cassette to an different cassette from the same box, the infusion was working as normal and the patient received the medication as expected. The patient was affected because the chemotherapy was delayed, and the patient had to stay at the hospital overnight. There were no reported averse events.
 
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Brand NameCADD
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
david halverson
6000 nathan lane north
postboks 93 kjelsas
minneapolis, MN 55442
MDR Report Key12067245
MDR Text Key258342377
Report Number3012307300-2021-06535
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
K081156
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 06/25/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7308-24
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/28/2021
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
Type of Device Usage Unkown

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