Recurrent Medical Device Reporting on Issues Experienced With a Hemodialysis System Leads to Manufacturer Action

Medical device reporting of one-time or recurrent medical device–related issues can provide critical safety information that the US Food and Drug Administration (FDA) uses to help protect and promote the public health. Medical device reports can provide essential information about the severity of medical device–related concerns and include key details that, in conjunction with other similar reports, can help FDA investigate the device concern with the device manufacturers. The enclosed (included) case study involves multiple medical device reports detailing various issues with different components of a single complex medical device system and describes how the multiple and recurrent reports prompted FDA to follow up with the manufacturer, which ultimately helped support manufacturing changes that addressed the reported issues.