Recipient:Cincinnati Sub-Zero Products, Inc.
Product:Blanketrol II, Blanketrol III, Electri-Cool II, Micro-Temp LT, Hemotherm, Norm-O-Temp, Extra Corporeal Membrane Oxygenation Blood Temperature Control System, and Warm Air Hyperthermia System
Failure to establish and maintain adequate procedures for validating the device design, including software, to ensure that devices conform to user needs and intended uses and include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g). For example, the software used in the microprocessor boards on the Blanketrol II device does not have a software validation protocol established and the software has not been validated. You were unable to determine how many software revisions had been released for the Blanketrol II and what changes were made during each revision.
We have reviewed your responses and have concluded that they are inadequate because you have not completed your review and validations for all products that require software validation. You have stated that you have completed a software validation for the current version of the Blanketrol II device, but no documented evidence was provided for our review. You opened a corrective action and identified five other devices requiring software validation in the response dated 2/26/10. The effectiveness ofthe evidence and implementation of the correction, the corrective action, and the proposed preventive action cannot be determined. Additionally, you have not determined the fundamental cause for a systemic failure to validate software, and no corrective action or preventive action to correct the systemic failure has been taken and determined to be effective.
Issuing Office: Cincinnati District Office