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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. RESERVOIR, CASSETTE 100ML SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. RESERVOIR, CASSETTE 100ML SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 21-7302-24
Device Problems Failure to Deliver (2338); Device Displays Incorrect Message (2591)
Patient Problem Insufficient Information (4580)
Event Date 06/23/2021
Event Type  malfunction  
Event Description
Patient on outpatient infusion using cadd-legacy plus infusion pump (21-6500-51) with reservoir, cassette 100ml (product id# 21-7302-24, lot#4096352 from smiths medical). Pump fails to give entire dose of fluorouracil. Error message, "no disposable, will not run" displays on the pump screen. Patient returned to clinic with 5. 1ml remaining of this dose. Reached out to pump vendor who states the issue is with the reservoir, cassette. Error message occurred with other patients at this hospital. Fda safety report id# (b)(4).
 
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Brand NameRESERVOIR, CASSETTE 100ML
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key12099350
MDR Text Key260072467
Report NumberMW5102222
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 06/28/2021
2 Devices were Involved in the Event: 1   2  
0 Patients were Involved in the Event:
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number21-7302-24
Was Device Available for Evaluation? Yes
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? No
Type of Device Usage

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