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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 21-7052-24
Device Problem Connection Problem (2900)
Patient Problems Diarrhea (1811); Headache (1880)
Event Date 02/01/2021
Event Type  malfunction  
Event Description
Information was received indicating that the cadd extension set became disconnected from the cassette end. It was reported that the patient went without medications for several hours due to the malfunction. The patient's diagnosis is pulmonary arterial hypertension. The patient felt unwell. Then had to endure side effects of sudden start of medication when reconnected (headache, flushing, diarrhea) which lasted in one of the cases for a couple of days. It was a significant contributor to patient anxiety. To continue therapy, the patient reattached and remade her medication as needed and symptoms resolved.
 
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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
glossop road
minneapolis, MN 55442
MDR Report Key11408734
MDR Text Key234615736
Report Number3012307300-2021-01732
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
K974013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/04/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7052-24
Device Lot Number4025966
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/19/2020
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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