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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 21-7323-24
Device Problems Insufficient Flow or Under Infusion (2182); Pressure Problem (3012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/24/2021
Event Type  malfunction  
Event Description
Information was received indicating that the cadd administration sets - flow stop might have contributed to causing an infusion issue and a high-pressure error. It was also reported that when the tubing is used without the anti-siphon valve it works fine. The patient did not receive the entire amount of chemotherapy due to this issue, but there were no adverse events reported. When the tubing was changed, medication was administered and completed as intended.
 
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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
minneapolis, MN 55442
MDR Report Key11407596
MDR Text Key234993005
Report Number3012307300-2021-01712
Device Sequence Number1
Product Code FPA
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 health professional
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7323-24
Device Lot Number4066501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/11/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/26/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/11/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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