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


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 
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 
Telephone: +49 5661 712 769 
Fax: +49 5661 752 769 

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 

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 

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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