Here are a few examples of product-related systemic issues.
Example 1
An infusion pump did not prevent free-flow if the access door was opened. Clearly, this is a systemic issue! Any time the door is open and the set is installed, uncontrolled flow to the patient may occur.
Example 2
Recently, there has been a spate of infections attributed to cross-contamination from duodenoscopes. The scopes were not or could not be cleaned sufficiently to eliminate all the contaminants. Had this occurred once, it may have been attributable to a single instance of poor cleaning. Since there were frequent occurrences, the company had to conclude this was a systemic issue.
Example 3
After numerous production runs of many pieces, a batch resulted in a high number of parts that did not fit its mating part (non-conforming to specifications). The frequency of failure was well outside the process limits so it was considered a systemic issue.