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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION
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ST PAUL CADD; PUMP, INFUSION Back to Search Results
Device Problems Device Alarm System (1012); No Flow (2991)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Event Description
It was reported that the pump exhibited a low reservoir alarm and that the morphine bag was full.It was unknown if there were any adverse patient effects.
 
Manufacturer Narrative
Other text: a supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: model number, catalog number, serial number, udi, g5, and h4 are unknown.
 
Manufacturer Narrative
No product was returned.The investigation determined the most probable cause to be due to an unintentional user error, however this cannot be confirmed as no product was returned for investigation.If the product is returned this complaint will be reopened for further investigation.No serial number was provided; therefore, a history record review could not be conducted.G1, email address: (b)(6).
 
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Brand Name
CADD
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section G)
NULL
Manufacturer Contact
jim vegel
MDR Report Key17908345
MDR Text Key326256952
Report Number3012307300-2023-09601
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/10/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/02/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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