Background: During the Summary of Clinical Review for the Premarket Study presented at the FDA, it was noted that a particular model of pediatric left ventricular assist device (LVAD) is prone to thrombus formation at the inlet and outlet valves, and therefore increased mortality may be expected when

Background: During the Summary of Clinical Review for the Premarket Study presented at the FDA, it was noted that a particular model of pediatric left ventricular assist device (LVAD) is prone to thrombus formation at the inlet and outlet valves, and therefore increased mortality may be expected when:

It is implanted at relatively less-experienced centers (<100/year)

Patients present with single ventricle physiology

Patients require pre-implant ECMO support

Nevertheless, FDA determined that the clinical risk benefit profile was acceptable and approved the device as a bridge to transplant (BTT) for pediatric patients when a compatible human heart is not immediately available.

Scenario: A left ventricular assist device is surgically implanted into a 3-month-old patient under general anesthesia at a surgical center that performs an average of 85 such surgeries per year, although the cardiovascular surgeon assigned to this case performs almost all of these surgeries himself. The patient had a compromised immune system prior to the surgery, as she was recovering from a virus and pneumonia induced by a chronic pulmonary edema due to poor cardiac function. This required her to be on both cardiac and respiratory support for two weeks prior to surgery. The surgery proceeded without incident, and the patient was returned to a special cardio-neonatal ICU to recover. The ICU was not staffed over the weekend with the most experienced nurses, as it was a long holiday weekend, and the most senior nursing staff had been approved for vacation well in advance. Therefore, when a pressure alarm in the outlet valve of the LVAD sounded in the ICU, the attending nurse applied suction to the inlet valve, and the thrombus blocking the outlet valve resulted in the infant’s death. The hospital explanted the LVAD post-mortem and returned it to the manufacturer for assessment. The hospital reported the event to both the FDA and the manufacturer of the LVAD (via MDR), and the manufacturer conducted an internal investigation into the situation, using the returned, explanted LVAD. It was determined that there had been an increase in the rate of thrombus formation complaints on the device in the lot numbers of LVADs produced around the same time as the LVAD in question. The manufacturer’s Quality Engineer opened a CAPA. During the CAPA investigation, the engineer determined that the supplier of the outlet valve had been changed recently, and the new supplier had failed its unannounced audit by its Notified Body due to a non-validated metal polishing process. Further investigation revealed that the outlet valve on the explanted LVAD contained metal burrs that could encourage thrombus formation. After completing the investigation, the explanted device was placed into a general (non-biohazard) refuse bin by the engineer investigating the MDR.

Assignment:

List all harms, hazards and hazardous situations in the scenario presented.   Be sure to identify each item as a harm, hazard or hazardous situation.