Service Bulletin Statement Battery Life for Space Pumps

B. Braun Melsungen AG Division Hospital Care Marketing a Sales 34209 Melsungen Germany 30.10.2013 e-mail: [email protected] http://www.bbraun.de

Statement: Battery life for Space Pumps To whom it may concern, As a medical device manufacturer B. Braun takes patient safety and product quality very seriously. Although there have been no reports of adverse patient incidents there may be a risk when the Perfuso:r® Space pump is used with an aged battery that the pump may not have sufficient current to perform a syringe change, despite the battery indicator on the pump showing fuH charge. This is because a syringe change requires a large current which may not be available if the battery has been significantly aged. This does not affect running infusions. The issue can only occur when the pump is not connected to the mains (for example during patient transfer) and is particularly relevant for patients on life sustaining or other critical medications. Over time, batteries in any medical device will degrade. This results in an increased internal impedance and so batteries should be tested or replaced after four years. Service documents have been updated to include details of how to identify the age of the battery, the battery replacement recommendations and the test procedure. In addition, clinical staff are reminded that for infusions of critical medications, always to have an additional pump available in accordance with the Perfuso:r® Space Instructions for Use (section: PATIENT SAFETY).

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Klaus Vice President Marketing Drug Admixture a Application Systems

James Product Manager Drug Admixture a Application Systems

Chairman of Supervisory Board: Prof. Dr. h.c. Ludwig Georg Braun

Executive Board: Prof. Dr. rer. pol. Heinz-Walter Große Prof. Dr. med. Hanns-Peter Knaebel (Chairman) Dr. rer. nat. Meinrad Lugan Dr. rer. pol. Annette Beller Caroll H. Neubauer, LL.M. Dtto Philipp Braun Markus Strotmann (Deputy member)

Address: Corporate Office: Melsungen Register Court: Local Court Fritzlar B. Braun Melsungen AG HRB 11 000 Carl-Braun-Straße 1 34212 Melsungen WEEE-Reg.-No. DE 42690900 Germany