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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL, INC. SET EXT 60IN W/ .2 MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL, INC. SET EXT 60IN W/ .2 MICRON FILTER SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Lot Number 3521571
Device Problem Fluid Leak (1250)
Patient Problem Dyspnea (1816)
Event Date 02/23/2020
Event Type  malfunction  
Event Description
Pt reported leaking from end cap of icu medical. Stated leaking started yesterday and cap was changed. Pt reported having shortness of breath last night, but denied symptoms this morning. No further details provided.
 
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Brand NameSET EXT 60IN W/ .2 MICRON FILTER
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL, INC.
MDR Report Key9840323
MDR Text Key183902437
Report NumberMW5093778
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Pharmacist
Type of Report Initial
Report Date 02/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number3521571
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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