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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION, ENTERAL
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SMITHS MEDICAL ASD, INC. CADD; PUMP, INFUSION, ENTERAL Back to Search Results
Model Number 1400
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/03/2020
Event Type  malfunction  
Event Description
Information was received indicating that it was "suspected" that a patient using a smiths medical cadd-legacy duodopa ambulatory infusion pump was requesting extra boluses which resulted in overdosing.Per reporter the bolus was subsequently locked to three (3) hourly.It was also reported that the patient's inner tube had fallen out multiple times.No adverse patient effects were reported.
 
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Brand Name
CADD
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 Key10092367
MDR Text Key192191536
Report Number3012307300-2020-05022
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 05/27/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model Number1400
Device Catalogue Number21-1400-51
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received04/28/2020
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 N
Patient Sequence Number1
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