FDA 483 - Umass Memorial Medical Center Stem Cell Cryopreservation Lab - December 11, 2015

This FDA Form 483 documents observations from an inspection of a hospital/user facility. The primary issues identified relate to deficiencies in the Medical Device Reporting (MDR) procedure and associated documentation.

Specifically, the written MDR procedure lacks an internal system for timely and effective identification, communication, and evaluation of events subject to reporting requirements. Several instances of failure to submit MDRs within the required 10 working days were noted: A) For incident (b)(3), involving patients infected with (b)(3) and (b)(3) where (b)(3) were used, resulting in 3 patient deaths. B) For incident (b)(3), concerning an (b)(3) associated with a (b)(3).

Additionally, timeframes for submitting MDR reports to FDA and manufacturers through MedSun are not defined in the Risk Management Procedure. MDR event files have not been established and maintained. Despite participation in MedSun, the facility has not established and maintained documentation to determine device-related reportability. This includes: 1. The hospital's incident reporting system not being linked to MDR files and patient records. 2. The decision-making process for MDR reportability not being documented. 3. Absence of a corresponding business file for easy identification and access to MDR information.

Furthermore, the user facility failed to submit FDA Form 3500A or equivalent to the known device manufacturer within 10 working days for a serious