FDA Adverse Event Death Summary report: N

*

MDR report key: 1647317 · Received March 29, 2010

Report

Report Number
1647317
Event Type
Death
Date Received
March 29, 2010
Date of Event
March 25, 2010
Report Date
March 29, 2010
Manufacturer
MEDTRONIC PERFUSION SYSTEMS
Product Code
DTZ
Adverse Event
Yes
Product Problem
Yes
Report Source
User Facility report
Reporter Location
CA, US

Narratives

Description of Event or Problem · 1

THE PT WAS BORN WITH A CONGENITAL DIAPHRAGMATIC HERNIA WITH A POOR PROGNOSIS. THE PARENT REQUESTED EVERYTHING TO BE DONE. THE INFANT CONTINUED TO DETERIORATE AND THE PARENTS CONSENTED TO ECMO. AFTER CANNULATING THE PT, AIR WAS NOTED IN THE CIRCUIT. IT IS UNCLEAR IF AIR REACHED THE PT. THE ECMO FLOW WAS IMMEDIATELY STOPPED. THE PT WAS CODED AND PLACED ON LVAD AS A TEMPORARY MEASURE. THE INFANT WAS STABILIZED ON LVAD. THE PARENTS WERE NOTIFIED BY THE MDS AND REQUESTED TO CONTINUE THE SUPPORT OF THE INFANT. THE INFANT WAS TRANSITIONED BACK TO A DIFFERENT ECMO CIRCUIT THE NEXT DAY WITHOUT INCIDENT. THE PARENTS ELECTED TO TRANSITION THE PT TO COMFORT CARE, AND APPROXIMATELY AN HOUR LATER, THE INFANT EXPIRED. THE ECMO CIRCUIT WAS TESTED BY THE MD & RN. THE OXYGENATOR GAS WAS CAPPED OFF, THERE WAS NO AIR ENTERING THE CIRCUIT; HOWEVER, WHEN FLOW WAS RESTARTED, AIR ENTERED THE CIRCUIT. THE HEALTHCARE PROFESSIONALS SUSPECTED THERE MAY HAVE BEEN A BREACH BETWEEN THE GAS PATH AND BLOOD PATH OF THE OXYGENATOR. THERE WAS NO EVIDENCE THAT THE INFANT ACTUALLY SUFFERED AN AIR EMBOLISM AS A RESULT OF THE EVENT. THERE WAS A HEAD ULTRASOUND DONE THE NEXT DAY AND IT DID NOT SHOW ANY INJURY (HEMORRHAGE OR INFARCT) COMPARED TO THE ULTRASOUND THAT WAS DONE PRIOR TO ECMO. EVEN IF A TINY BIT OF AIR MAY HAVE GOTTEN INTO THE INFANT'S SYSTEM, THE UNDERLYING DISEASE DICTATED THE SUBSEQUENT COURSE OF EVENTS.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1 * OXYGENATOR, CARDIOPULMONARY, BYPASS DTZ MEDTRONIC PERFUSION SYSTEMS 1500 *

Patients

Seq Age Sex Outcome Treatment
1 1 DA Death