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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC CUSTOM PERFUSION SYSTEM
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MEDTRONIC CUSTOM PERFUSION SYSTEM Back to Search Results
Model Number ADULTE
Device Problems Inadequate Instructions for Healthcare Professional (1319); Connection Problem (2900)
Patient Problems Death (1802); Hypoglycemia (1912); Right Ventricular Hypertrophy (2056)
Event Date 12/05/2016
Event Type  Death  
Event Description
Pt was hemodynamically unstable with respiratory failure and required ecmo support.Arterial and venous cannulas were inserted via left groin after heparinization.Cannula position was confirmed by tee ecmo circuit was brought to surgical field.Circuit has two ends, which were labeled red and blue by mfr.The red cannula should connect to arterial access for perfusion, and the blue cannula should connect to venous access for drainage, which was completed.Once ecmo was initiated, pt was found to be hypotensive (30-40mmhg) with right ventricular distention.Ecmo was not flowing sufficiently, and perfusionist found circuit connection was wrong; red labeled line was venous, and blue labeled line was arterial.Diagnosis or reason for use: failed completion pneumonectomy.Event abated after use stopped or dose reduced? no.
 
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Brand Name
CUSTOM PERFUSION SYSTEM
Type of Device
CUSTOM PERFUSION SYSTEM
Manufacturer (Section D)
MEDTRONIC
minneapolis MN 55432
MDR Report Key6194142
MDR Text Key63066640
Report NumberMW5066830
Device Sequence Number1
Product Code KFM
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 12/19/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2017
Device Model NumberADULTE
Device Catalogue NumberCB4W67R15
Device Lot Number211403627
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received12/19/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age54 YR
Patient Weight65
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