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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR
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ST PAUL CADD MEDICATION CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Power Problem (3010)
Patient Problems Dyspnea (1816); Headache (1880)
Event Date 09/03/2022
Event Type  Injury  
Manufacturer Narrative
Catalog number, lot number, unique identifier (udi) and pma/510(k) number are unknown.No information has been provided 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 the pump switched off during infusion.The patient had experienced shortness of breath and headache.
 
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Brand Name
CADD MEDICATION CASSETTE
Type of Device
SET, 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
minneapolis, MN 55442
MDR Report Key15417257
MDR Text Key299845439
Report Number3012307300-2022-19084
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 User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial
Report Date 09/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/08/2022
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
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age41 YR
Patient SexFemale
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