• 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® DUODOPA PUMP; PUMP, INFUSION, ENTERAL

  • 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® DUODOPA PUMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 1400
Device Problems Device Alarm System (1012); Battery Problem (2885)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).This device is same and/or similar to a device approved for distribution in the us.One used cadd-legacy® duodopa pump was received for investigation.Through visual inspection, it was confirmed that the pump's battery door was difficult to operate as a result of contamination from a leaking battery.A root cause for the leaking battery could not be determined.
 
Event Description
It was reported that the patient's wife could not replace the batteries of a cadd-legacy® duodopa pump because the battery compartment would not open.The pump displayed a "batteries low" message.It was reported that the patient fell "some time ago", and wondered if the fall could be linked to the error message.The patient's wife later reported that the pump gave an alarm with three tunes every five minutes.It is unclear whether that alarm was a high pressure alarm or a low battery alarm.The patient's wife still was unable to open the compartment to replace the batteries, however, the pump still displayed "running".The patient's wife later reported the same issue; low batteries, compartment stuck, pump running.The patient was provided with a new pump.No injury was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD-LEGACY® DUODOPA PUMP
Type of Device
PUMP, INFUSION, ENTERAL
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7434343
MDR Text Key105683919
Report Number3012307300-2018-01276
Device Sequence Number1
Product Code LZH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,foreign
Reporter Occupation Other
Type of Report Initial
Report Date 04/16/2018
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 Patient Family Member or Friend
Device Model Number1400
Device Catalogue Number21-1400-02
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/21/2018
Initial Date FDA Received04/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age78 YR
-
-