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 AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA
  • 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 AMBULATORY INFUSION PUMP; PUMP, INFUSION, PCA Back to Search Results
Model Number 2110
Device Problem Device Alarm System (1012)
Patient Problem Insufficient Information (4580)
Event Date 03/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3: event date unknown.One device was returned for evaluation.Visual inspection revealed a downstream occlusion (dso) seal bubble.Event history log review was not required.Functional testing was able to replicate the reported issue; ¿cassette not attached properly¿ was displayed on the pump.The root cause was determined to be a non-functional dso sensor.The dso sensor was replaced.Service history review identified there was no indication that the complaint was related to a service of the device within the review period.
 
Event Description
It was reported that the device exhibited a cassette alarm.There was unknown patient involvement and unknown patient harm.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD-SOLIS AMBULATORY INFUSION PUMP
Type of Device
PUMP, INFUSION, PCA
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan ln n
minneapolis MN 55442
Manufacturer Contact
reed covert
6000 nathan lane north
minneapolis, MN 55442
2247062300
MDR Report Key19093515
MDR Text Key340631179
Report Number3012307300-2024-02477
Device Sequence Number1
Product Code MEA
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K170982
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/11/2024
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 Health Professional
Device Model Number2110
Device Catalogue Number21-2111-0401-51L
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/13/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/11/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
-
-