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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 409-6350
Device Problem Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 05/21/2021
Event Type  malfunction  
Event Description
Inbound, patient reports no disposable clamp tubing alarm with cadd cassette 100 ml with flowstop, lot number 4096350, expiration date 01/25/2026. Available for return, replacement cassettes sent. 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 Key12057191
MDR Text Key258325369
Report NumberMW5102065
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 05/21/2021
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 Number409-6350
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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