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: SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMP; 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
 

SMITHS MEDICAL ASD, INC. CADD SOLIS VIP PUMP; PUMP, INFUSION Back to Search Results
Model Number 2120
Device Problem Excess Flow or Over-Infusion (1311)
Patient Problems No Patient Involvement (2645); No Information (3190)
Event Type  malfunction  
Manufacturer Narrative
One cadd solis vip pump was received with a damaged lens.The event history log was reviewed and there was no evidence of the reported issue.Accuracy testing was conducted and the reported over infusing issue was duplicated.The device was pumping slightly above the nominal 3%.The explusor was out of specification.The expulsor will be trimmed to resolve the issue.
 
Event Description
Information was received indicating that a smiths medical cadd solis vip pump was over infusing.There was no reported adverse event.
 
Manufacturer Narrative
Additional information: information was received on 5-mar-2020 indicating that there was no patient involvement in the event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD SOLIS VIP PUMP
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis, mn
MDR Report Key9772578
MDR Text Key181535121
Report Number3012307300-2020-01744
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10610586042829
UDI-Public10610586042829
Combination Product (y/n)N
PMA/PMN Number
K111275
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial,Followup
Report Date 04/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2120
Device Catalogue Number21-2120-0102-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/14/2020
Date Manufacturer Received03/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-