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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2-MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR

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SMITHS MEDICAL ASD, INC. CADD EXTENSION SET 0.2-MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 58X056
Device Problems Air Leak (1008); Leak/Splash (1354)
Patient Problem Dyspnea (1816)
Event Type  malfunction  
Event Description
Outbound. Patient informed nurse extension tubing is leaking from the filter. Patient also reports more short of breath than yesterday. Large air bubble noted in cassette attached to patient. No further information available. Lot number: 58x056.
 
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Brand NameCADD EXTENSION SET 0.2-MICRON FILTER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
MDR Report Key7605160
MDR Text Key111399587
Report NumberMW5077870
Device Sequence Number0
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 06/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2018
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number58X056
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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