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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD® MEDICATION CASSETTE RESERVOIR SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 6400
Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2018
Event Type  malfunction  
Event Description
Information was received indicating that "no disposable tubing" error occurred to a smiths medical cadd® medication cassette reservoir. The patient's mother reported that the attached cassette was causing the error by pinching the tubing; not allowing infusion to run. The backup pump was then started with the same error occurring. It was noted that the mother was going to change out the cassette once at home. No adverse effects were reported.
 
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Brand NameCADD® MEDICATION CASSETTE RESERVOIR
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC
1265 grey fox rd
st. paul MN 55112
Manufacturer Contact
dave halverson
6000 nathan lane n
minneapolis, MN 55442
7633833310
MDR Report Key7456893
MDR Text Key106407143
Report Number3012307300-2018-00993
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Patient Family Member or Friend
Device Model Number6400
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/02/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberMW5075863

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