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U.S. Department of Health and Human Services

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

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SMITHS MEDICAL ASD, INC. CADD MEDICATION CASSETTE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Device Problem Insufficient Flow or Under Infusion (2182)
Patient Problems Dyspnea (1816); Confusion/ Disorientation (2553)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Adverse event|required intervention to prevent permanent impairment/damage.
 
Event Description
Information was received indicating that a smiths medical, cadd medication cassette did not attach correctly, patient did not hear an alarm, resulting in patient being off remodlin for about 36 hours, infusion information reported was 10mg, dose, 210ng. Kg. Min, at a continuous rate intravenously. Treatment for pulmonary arterial hypertension. It was reported the patient was advised by support and the doctors office to go to the emergency room as the patient was exhibiting some shortness of breath and difficulty with focus. Per reporter the patient stated the pump was working and the cassette was the issue. It was also reported the product fault may have contributed to injury, although no further information was supplied.
 
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Brand NameCADD MEDICATION CASSETTE
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
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key13060679
MDR Text Key282624743
Report Number3012307300-2021-13156
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/22/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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