Provider Alert: Early Alert: Infusion Pump Issue from Fresenius Kabi USA
This week, we are sharing the following provider updates —
S: A Recall Safety Alert has been identified in alignment with the FDA’s Communication Pilot to Enhance the Medical Device Recall Program. The recall affects an Infusion Pump Issue from Fresenius Kabi USA.
B: On December 5, Fresenius Kabi USA sent all affected customers a letter that included recommendations for action regarding the affected devices.
A: Reason for Early Alert: “Fresenius Kabi USA reports that a subset of pneumatic valves installed in some Ivenix LVPs have an increased chance of issuing a non-recoverable pump problem alarm. All devices with the affected valves should be removed from use.
R: SBAR notification to Medical Directors for awareness and Recall Notification Alert submitted for inclusion on the Website and in the Provider Newsletter
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Early Alert: Infusion Pump Issue from Fresenius Kabi USA
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