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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE 100ML W/FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD CASSETTE 100ML W/FLOWSTOP SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 4096351
Device Problem Device Alarm System (1012)
Patient Problem Lethargy (2560)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
Inbound. Patient reported she called emergency services to her home. The heart monitor had frequent premature ventricular contractions when veletri was not infusing due to a disposable pump alarm on (b)(6) 2021 and that both pumps were alarming. The res volume of cassette was 65 milliliters. After a new cassette was mixed, veletri was restarted in the home and she did not go to the hospital. She started feeling better in 30 minutes. She is feeling tired and weak today from the stress. The lot number of a cassette from the same box was 4096351. No further details provided.
 
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Brand NameCADD CASSETTE 100ML W/FLOWSTOP
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12057233
MDR Text Key258372770
Report NumberMW5102067
Device Sequence Number1
Product Code FPA
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 05/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number4096351
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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