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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS VIP PUMP; PUMP, INFUSION, PCA
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ST PAUL CADD SOLIS VIP PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2111
Device Problem Improper Flow or Infusion (2954)
Patient Problems No Information (3190); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/13/2021
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd solis hpca pump's infusion accuracy was not within test specifications.There was no reported adverse event.
 
Event Description
Additional information received indicated that the issue was discovered during preventative maintenance.
 
Manufacturer Narrative
Device evaluation: one cadd solis hpca was returned for analysis.Accuracy testing was performed and the operator was unable to duplicate the customer's problem, three separate delivery accuracy tests were performed.The pump was slightly over delivering but within the published plus or minus 6 percent specification.It's recommend that the pump's expulsor be trimmed in order to bring the delivery into more nominal of a range.
 
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Brand Name
CADD SOLIS VIP PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key11322007
MDR Text Key231617623
Report Number3012307300-2021-01200
Device Sequence Number1
Product Code MEA
UDI-Device Identifier15019517099690
UDI-Public15019517099690
Combination Product (y/n)N
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 03/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number2111
Device Catalogue Number21-2111-0401-51
Was Device Available for Evaluation? No
Date Returned to Manufacturer01/22/2021
Was the Report Sent to FDA? No
Date Manufacturer Received02/22/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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