CAPA [redacted] was opened on May 25, 2011 to address Plum A+ pump battery failures which can cause a delay or interruption of critical therapy. Your firm has failed to implement the identified corrective actions in this CAPA, such as a software upgrade to change the risk profile; battery replacement to reduce the probability of occurrence; battery supplier approval with increased controls; and notification to customers, despite the fact that your firm has received 311 complaints for code E321 documenting battery failures and 11 MDRs documenting a stoppage of critical drug delivery as of January 31, 2013. Plum A+ infusion pump: Review of the “analysis” data field for Plum A+ complaints revealed failures of the bubble sensor printed wire assembly within the printed circuit board, battery, touch key pad assembly and front case assembly.
In addition, the failed components are not identified as a data source for analysis nor are they trended in your CAPA system to assess whether a preventive or corrective action is indicated and to ensure that components are performing according to infusion pump design specifications.
View the original warning letter.