Based on the investigation and additional information received, siemens medical affairs identified this issue as low health risk (lhr) on (b)(6) 2015.As per procedure, siemens did retrospective review of all associated complaints with this issue and identified those with potential safety issues for which medical device reports need to be filed.Siemens is revising the affected acute care testpak, calpak, and dilpak labeling to resolve this issue.Siemens issued an urgent field safety notice (33714 rev.A) to notify affected siemens customers about this issue in november 2015.
|