Shots:

• Smith Medical has recalled its Medfusion 4000 syringe pump with firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy. The FDA has labeled it as Class I recall
• The 627 devices have recalled having model numbers are 4000-0107-01 and 4000-0106-01- manufactured on Jun 25- 2019- and distributed b/w Sept 27- 2019- and Oct 31- 2019. The company has received 74 complaints related to software update while no injuries and death have been reported
• The Medfusion 4000 syringe pump is used to deliver blood- blood products or prescribed drugs into a patient’s body in a controlled manner. The malfunctioning in the battery alarm- the HCPs using the pump will not receive audible/ visual notification that the battery is shutting down which may lead to an interruption of therapy causing serious injury- AEs or death

Click here to read full press release/ article | Ref: The US FDA | Image: Signbox