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U.S. Department of Health and Human Services

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

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ST PAUL CADD MEDICATION CASSETTES SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Connection Problem (2900)
Patient Problems Diarrhea (1811); Headache (1880); Swelling/ Edema (4577)
Event Type  malfunction  
Manufacturer Narrative
No product or photographic evidence were provided to aid in this investigation. The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications. Lacking any additional evidence, this complaint has been closed as unconfirmed. If the product is returned, smiths medical will reopen this complaint for further investigation. No lot number provided for dhr.
 
Event Description
It was reported that the patient reported occasional shortness of breath, fatigue and swelling in her legs, feet and hands. Patient advised she can tell improvement in how she feels since starting remodulin. Pt has had 1 day of diarrhea and occasional headache since starting remodulin. Patient reported she has clots in her legs and lungs and hopes to get well. Enough to have surgery to remove them. Pt reported her cassettes have been going haywire but she called to our nursing line last night and they were able to troubleshoot and correct issue. No further details provided.
 
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Brand NameCADD MEDICATION CASSETTES
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
jim vegel
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key14161310
MDR Text Key289670794
Report Number3012307300-2022-06728
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received03/23/2022
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

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