• 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 AMBULATORY INFUSION 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 AMBULATORY INFUSION PUMP; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 1400
Device Problems Obstruction of Flow (2423); Human-Device Interface Problem (2949)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Event Description
Information was received indicating that a smiths medical cadd-legacy duodopa ambulatory infusion pump had a kinked tube and alarmed for "overpressure" during delivery of the morning dose.Per reporter the nurse thought that the alarm was a low battery alarm, changed batteries and when the pump was turned on again saw that "the morning dose was 2.7 ml and then she increased it again to 3.5 ml." it was reported that the nurse then had doubts and called the hotline, and it was determined that the alarm was "overpressure" and the 2.7 ml was the amount the patient had not received because of the alarm.Per reporter the morning dose was to be subsequently changed back to 3.2 ml the next morning.Follow up has been made to the reporter to confirm if the patient received the additional 3.5 ml dose.No adverse patient effects were reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CADD-LEGACY DUODOPA AMBULATORY INFUSION 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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10245520
MDR Text Key197961982
Report Number3012307300-2020-07010
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 company representative,distri
Reporter Occupation Other
Type of Report Initial
Report Date 07/08/2020
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 Lay User/Patient
Device Model Number1400
Device Catalogue Number21-1400-03
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/17/2020
Initial Date FDA Received07/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
-
-