On June 5, 2013, a nuclear medicine scanner was being used for a diagnostic procedure at a New York Veterans Affairs (VA) medical center when the gamma camera collapsed on a patient, causing his death. This issue can be examined in a Cause Map, or visual root cause analysis, in order to determine both the impact to the organization’s goals as well as the causes of the incident.
In this case, multiple goals were impacted, the first and foremost of which is the death of a patient. This is an impact to the patient safety goal. Had the camera collapsed at a different time, it could have also injured an employee, causing an impact to the employee safety goal as well. The death of a patient due to a medical device that functions other than designed is a “Never Event“, or an event that should never happen in a medical facility. The scanner collapse on a patient clearly does not meet the goals for patient services. The property goal is impacted due to potential damage to the scanner. (None of the publicly released reports specified how much damage, if any, was caused to the scanner and camera.) The scanners of this type from this manufacturer were recalled shortly after this incident, impacting the operations goal and necessitating inspection and/or maintenance activities provided by the manufacturer, an impact to the labor time goal.
Investigation conducted shortly after this patient’s death determined the collapse was caused by loose bolts. The machines were quickly subject to a Class 1 recall with the FDA. Sites with the recalled equipment were told to discontinue use until inspections and, if needed, preventive maintenance could be performed by the manufacturer. Said the manufacturer’s spokesperson, “If no issue is found with the support mechanism fasteners, the site can resume use of the device. If an issue with the support mechanism fasteners is found on a system, the GEHC Field Engineer will coordinate the replacement of impacted parts, and ensure that the system is operating appropriately and meets all specifications.”
Publicly released information about the incident has not specified who was responsible for the preventive maintenance that may have determined the need for tightening the bolts. However, inspection and maintenance costs were covered by the manufacturer of the devices.
Sites that are using the affected models should have been notified and should stop use until the recommendations of the recall are met. Although details of broader solutions were not available, both the manufacturer of the devices and the healthcare facilities using them will surely take a look at the preventive maintenance schedule to decrease the risk of patient injury from this type of event.
To view the Outline and Cause Map, please click “Download PDF” above. Or click here to read more.