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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 Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 05/24/2021
Event Type  malfunction  
Event Description
Inbound, patient stated pump sn (b)(4) started. Alarming no disposable tubing, patient switched to backup pump without alarm resolving, used new cassette with first pump with similar alarm, used new cassette with backup pump. Pump working without complication. Cassette lot number 4096351. Pump replacement 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 Key12057201
MDR Text Key258377106
Report NumberMW5102066
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
2 Devices were Involved in the Event: 1   2  
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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