Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ST PAUL CADD; PUMP, INFUSION Back to Search Results
Model Number 21-2111-0300-01
Device Problem Device Displays Incorrect Message (2591)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Event Description
Information received that a cadd solis hpca was not showing correct amount of mil.No adverse effects reported.
 
Manufacturer Narrative
H3: one cadd solis hpca pump was received with no physical damage.There was no evidence of the reported issue in the event history log.An accuracy test was performed and the reported accuracy issue was unable to be confirmed.Delivery accuracy testing found the pump's average delivery error to be within the published specification of +/-6%.The pump delivered properly and the display was found to be operating properly and showing the correct amount of delivery.There was no fault found with the returned pump.
 
Manufacturer Narrative
Other, other text: report updated de to additional information received by smiths medical on 28-jul-2020.No patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
ST PAUL
1265 grey fox rd.
st. paul MN 55112
MDR Report Key10320977
MDR Text Key200252133
Report Number3012307300-2020-07540
Device Sequence Number1
Product Code MEA
UDI-Device Identifier10610586038778
UDI-Public10610586038778
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup,Followup
Report Date 10/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number21-2111-0300-01
Device Catalogue Number21-2111-0300-01
Was Device Available for Evaluation? No
Date Returned to Manufacturer07/16/2020
Was the Report Sent to FDA? No
Date Manufacturer Received09/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-