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 LEGACY 6400; 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 LEGACY 6400; PUMP, INFUSION Back to Search Results
Model Number 6400
Device Problems Device Alarm System (1012); Protective Measures Problem (3015)
Patient Problem No Information (3190)
Event Date 10/18/2019
Event Type  malfunction  
Manufacturer Narrative
Investigation results completed on a smiths medical cadd legacy 6400 pump.Event log revealed and substantiated complaint as alarms 1861 and 1820 occured.Testing done to duplicate event and is was isolated to motor.Action taken to replace motor.Unknown cause of event.
 
Event Description
Information received a smiths medical cadd legacy 6400 alarmed error 1861.No patient adverse events reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD LEGACY 6400
Type of Device
PUMP, INFUSION
Manufacturer (Section D)
SMITHS MEDICAL ASD,INC
6000 nathan lane
minneapolis, mn
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
5700 west 23rd avenue,
gary,, in
Manufacturer Contact
dave halverson
6000 lane n
minneapolis, mn 
3833310
MDR Report Key9772606
MDR Text Key181535510
Report Number3012307300-2020-01641
Device Sequence Number1
Product Code FRN
UDI-Device Identifier10610586019548
UDI-Public10610586019548
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K982838
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/29/2020
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 No Information
Device Model Number6400
Device Catalogue Number21-6400-51
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/04/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-