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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EDWARDS LIFE SCIENCES OPTI16 OPTI SITE CANNULA, 16 FRENCH

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EDWARDS LIFE SCIENCES OPTI16 OPTI SITE CANNULA, 16 FRENCH Back to Search Results
Lot Number 61800856
Device Problems Material Puncture/Hole (1504); Device Displays Incorrect Message (2591); Gas Leak (2946); No Flow (2991)
Patient Problems Death (1802); Embolus (1830); Neurological Deficit/Dysfunction (1982)
Event Date 05/31/2019
Event Type  Death  
Event Description
Ecmo circuit alarmed, lost flow noted. Air seen in cannula. Cannula removed and a hole was noted in the device. A head ct was concerning for air emboli. After the pt's neurologic decline, the family pursued comfort care and the pt expired.
 
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Brand NameOPTI16
Type of DeviceOPTI SITE CANNULA, 16 FRENCH
Manufacturer (Section D)
EDWARDS LIFE SCIENCES
one edwards way
irvine CA 92614
MDR Report Key8739261
MDR Text Key149481201
Report Number8739261
Device Sequence Number1
Product Code DQR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 06/14/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Lot Number61800856
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No Answer provided
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/14/2019
Event Location Hospital
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 06/21/2019 Patient Sequence Number: 1
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