service_bulletin_statement_battery_life_for_space_p.pdf
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B. Braun Melsungen AG
Division Hospital Care
Marketing a Sales
34209 Melsungen
Germany
30.10.2013
e-mail: james.green@bbraun.com
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).
LV
LA
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
(Chairman)
Dr. rer. pol. Annette Beller
Dtto Philipp Braun
Prof. Dr. med. Hanns-Peter Knaebel
Dr. rer. nat. Meinrad Lugan
Caroll H. Neubauer, LL.M.
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