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 REMOTE DOSE CORD; ACCESSORIES, 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 REMOTE DOSE CORD; ACCESSORIES, PUMP, INFUSION Back to Search Results
Catalog Number 21-2186-25
Device Problems Excess Flow or Over-Infusion (1311); Patient Device Interaction Problem (4001)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/01/2019
Event Type  malfunction  
Event Description
Information was received indicating that the patient fell asleep on the smiths medical cadd-solis remote dose cord.Per reporter, while patient was asleep on the cord, the button was "pushed sixty-four (64) times" and doses are "likely" to have been delivered while they were sleeping.It was reported that the duration of time and amount of doses given are unknown.No adverse patient effects were reported.
 
Manufacturer Narrative
Additional information that the cadd accessories was investigated by the supplier.According to the investigation the reported allegation was not confirmed.However, found supplied item fault and the problem source of the reported problem was supplier.
 
Manufacturer Narrative
Additional information received that the patient received hydromorphone.1mg with a lockout of 10 minutes with a 1 hour dose limit of 1.2 mg.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD-SOLIS REMOTE DOSE CORD
Type of Device
ACCESSORIES, PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
MDR Report Key9350215
MDR Text Key176305118
Report Number3012307300-2019-06124
Device Sequence Number1
Product Code MRZ
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 12/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number21-2186-25
Was Device Available for Evaluation? No
Date Manufacturer Received12/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CADD SOLIS INFUSION PUMP
-
-