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BBraun Perfusor Space Infusion Pump. Priority 2 - Warning
Notice type:
Warning
Date:
08/04/2014
Product name or type:
BBraun Perfusor Space Infusion Pump. Priority 2 - Warning
Reference:
SN2014(17)
Manufacturer Or Supplier:
B. Braun Melsungen AG
Target Audience:
A&E Departments
Ambulance Service
Anaesthetic medical/nursing staff
Biomedical Engineering staff
Cardiology Departments
Cardiothoracic Departments
Chief Executive Officers
Clinical Directors
Day Surgery Units
Emergency Medical Technicians
Gastroenterology Departments
Haemodialysis Units
High Dependency Units
Hospital Managers
Hospital Pharmacists
Intensive Care Units
IV Nurse Specialists
Maternity Units
Midwifery Departments
Neonatology Departments
Nursing Managers
Nursing staff
Obstetrics and Gynaecology Departments
Oncology Nurse Specialists
Orthopaedic Departments
Paediatric Departments
Paramedics
Peritoneal Dialysis Units
Purchasing Managers
Renal Medicines Departments
Resuscitation Officers
Risk Managers
Special Care Baby Units
Supplies Managers
Theatre Managers and nurses
Urology Departments
Problem Or Issue:
The Irish Medicines Board (IMB) wishes to remind users of a field safety notice (FSN) issued by B. Braun in December 2013. B. Braun has identified a risk that when the Perfusor 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 full charge.
The issue can only occur when the pump is not connected to the mains and presents a risk when the pump is used on battery only.
Background Information Or Related Documents:
BBraun Perfusor Space Infusion Pump. Priority 2 - Warning Document
The issue identified with the Perfusor Space infusion pump battery (or battery pack) may occur because a syringe change requires a large current which may not be available if the battery has been significantly aged.
See PDF version for copy of image.
Actions To Be Taken:
The IMB would like to remind users to:
(1) Follow the instructions outlined by the manufacturer in the FSN attached.
(2) Identify any batteries (or battery packs) of four years or older.
(3) Contact your Biomedical Engineering Department to arrange for replacement or testing of the battery (battery pack), as outlined in the device service manual.
(4) Always have an additional pump available for infusion of critical medications and during transport of patients.
(5) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information.
Further Information:
Enquiries to the
manufacturer
should be addressed to:
B.Braun Melsungen AG
Carl-Braun-Str.1
Melsungen
34212
Germany
Telephone: +49 5661 712 769
Fax: +49 5661 752 769
E-mail:
ludwig.schuetz@bbraun.com
Enquiries to the
distributor
should be addressed to:
B.Braun Medical
3 Naas Road Industrial Park
Dublin 12 Telephone: +353 1 709 1800
Fax: +353 1 709 1889
E-mail:
roberta.egan@bbraun.com
All adverse incidents relating to a medical device should be reported to:
Health Products Regulatory Authority
Human Products Monitoring
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
devicesafety@hpra.ie
Website:
www.hpra.ie
Please click here to view a PDF version of this safety notice
Please click here to view a copy of the field safety notice
Please click here to view a copy of the Service manual
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Date Printed: 26/04/2024