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 MD, INC. 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
 

SMITHS MEDICAL MD, INC. CADD; PUMP, INFUSION Back to Search Results
Model Number CADD SOLIS 2110
Device Problems Defective Device (2588); No Flow (2991)
Patient Problem Missed Dose (2561)
Event Date 12/29/2020
Event Type  malfunction  
Event Description
The epidural pump notified rn the reservoir was empty and needed a new bag of medication.Upon attempting to change the bag, rn noted bag to be full.Patient had not received any of the medication throughout the day.Anesthesia notified of issue and pump changed.
 
Event Description
The epidural pump notified rn the reservoir was empty and needed a new bag of medication.Upon attempting to change the bag, rn noted bag to be full.Patient had not received any of the medication throughout the day.Anesthesia notified of issue and pump changed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL MD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key11169603
MDR Text Key226805819
Report Number11169603
Device Sequence Number1
Product Code FRN
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/10/2021
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 NumberCADD SOLIS 2110
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/10/2021
Event Location Hospital
Date Report to Manufacturer01/14/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/14/2021
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/21/2021
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14235 DA
-
-