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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD SOLIS HPCA PUMP; PUMP, INFUSION
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ST PAUL CADD SOLIS HPCA PUMP; PUMP, INFUSION Back to Search Results
Model Number 2111
Device Problem Inaccurate Flow Rate (1249)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd solis hpca pump failed accuracy test by 8%.It was unknown if there was any patient involvement.There was no reported adverse event.
 
Manufacturer Narrative
One cadd solis hpca pump was received with no physical damage detected.The event history log was reviewed and there was no evidence of the reported issue.Accuracy test was performed and the reported accuracy issue was unable to be duplicated.Delivery accuracy testing found the pump's average delivery error to be within the published specification of +/-6%.There was no problem found with the returned pump.
 
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Brand Name
CADD SOLIS HPCA PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10089366
MDR Text Key192062286
Report Number3012307300-2020-04973
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 06/29/2020
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 Number2111
Device Catalogue Number21-2111-0401-51
Was Device Available for Evaluation? No
Date Returned to Manufacturer05/06/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 05/01/2020
Initial Date FDA Received05/26/2020
Supplement Dates Manufacturer Received06/01/2020
Supplement Dates FDA Received06/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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