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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD,INC. CADD® MEDICATION CASSETTE RESERVOIRS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number CADD CASSETTE RESERVOIRS - FLOW STOP
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Diarrhea (1811); Headache (1880)
Event Date 09/01/2019
Event Type  malfunction  
Manufacturer Narrative
No serial number was provided as the person reporting event believes may or may not be these numbers. (b)(6).
 
Event Description
Information received a smiths medical cadd® medication cassette reservoirs flow stop had under infused. The reported medication that is to infuse over twenty-four hours, has a rate of 3. 5 milliliters per hour, with sixteen milliliters left in usually the reservoir. Thirty milliliters was left remaining in cassette reservoir. A female consumer reported this to dr. (b)(6), on (b)(6), 2019. Symptoms of reported side effects of under dosing and concern for medication left in cassette, was headache and diarrhea. No patient permanent or life threatening injury reported.
 
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Brand NameCADD® MEDICATION CASSETTE RESERVOIRS
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.
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
dave halverson
6000 lane n
minneapolis, MN 55442
7633833310
MDR Report Key9325445
MDR Text Key175931854
Report Number3012307300-2019-06476
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCADD CASSETTE RESERVOIRS - FLOW STOP
Device Catalogue Number21-7302-24
Device Lot Number3776385
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/14/2019 Patient Sequence Number: 1
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