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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD-SOLIS VIP AMBULATORY INFUSION; PUMP, INFUSION
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ST PAUL CADD-SOLIS VIP AMBULATORY INFUSION; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
It was reported the device would not infuse.No adverse effects reported.
 
Manufacturer Narrative
One cadd solis vip pump was returned for analysis.Functional testing was performed.The device found no issue with no fluid is coming out the other end.The device also performed delivery accuracy and found three separate delivery accuracy test results which all were within the pump's delivery accuracy manufacturing specifications of plus or minus 6 percent.The device passed all functional tests.Therefore, no problems were found with the delivery accuracy of the pump.It's recommend to install software as preventive measure.
 
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Brand Name
CADD-SOLIS VIP AMBULATORY INFUSION
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10806788
MDR Text Key215259180
Report Number3012307300-2020-11249
Device Sequence Number1
Product Code FRN
UDI-Device Identifier15019517084368
UDI-Public15019517084368
Combination Product (y/n)N
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial,Followup
Report Date 01/14/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2120
Device Catalogue Number21-2120-0103-01
Was Device Available for Evaluation? No
Date Returned to Manufacturer10/15/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/09/2020
Initial Date FDA Received11/08/2020
Supplement Dates Manufacturer Received12/16/2020
Supplement Dates FDA Received01/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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