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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; SOLIS INFUSION PUMP
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ST PAUL CADD; SOLIS INFUSION PUMP Back to Search Results
Catalog Number 21-2111-0100-51
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Information (3190)
Event Type  malfunction  
Event Description
Information was received that device had delivery volume accuracy that was out of tolerance.No adverse effects reported.
 
Manufacturer Narrative
Returned device was received in good physical condition.No evidence of reported problem in event log was found.During the evaluation of the device, the reported issue was unable to be confirmed.Accuracy testing was all within specified range of +/-6%.No fault was found with the returned device but the expulsor was replaced as a preventative measure.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.
 
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Brand Name
CADD
Type of Device
SOLIS INFUSION PUMP
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10431456
MDR Text Key203677055
Report Number3012307300-2020-08348
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 10/27/2020
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 Catalogue Number21-2111-0100-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/22/2020
Initial Date FDA Received08/20/2020
Supplement Dates Manufacturer Received09/30/2020
Supplement Dates FDA Received10/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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