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B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps. Priority 2 - Warning

Notice type: Advisory

Date: 29/04/2014

Product name or type:
B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps

Reference:
SN2014(21)

Manufacturer Or Supplier:
B. Braun Melsungen AG

Target Audience:
All Hospital Staff
All Nursing Home Staff
A&E Departments
Ambulance Service
Anaesthetic medical/nursing staff
Biomedical Engineering staff
Cardiology Departments
Cardiothoracic Departments
Carers
Chief Executive Officers
Clinical Directors
Day Surgery Units
Emergency Medical Technicians
Gastroenterology Departments
Haemodialysis Units
Healthcare professionals who use these devices
Healthcare professionals managing patients who use these devices
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 / Procurement / Material Managers
Renal Medicines Departments
Resuscitation Officers
Risk Managers
Special Care Baby Units
Supplies Managers
Theatre Managers and nurses
Urology Departments

Problem Or Issue:
Risk of delay or interruption to therapy.

Issue 1: The Irish Medicines Board (IMB) has received an increased number of complaints in relation to breakage of the anti free-flow clip catch located inside the door of the B. Braun Infusomat Space infusion pump.

Issue 2: The IMB has received a number of complaints of pump detachment involving the B. Braun Pole Clamp when used to mount Infusomat and Perfusor Space pumps.

Background Information Or Related Documents:
B.Braun Infusomat & Perfusor Space Infusion Pumps & Pole Clamps. Priority 2 - Warning Document

Issue 1: Breakage of the anti free-flow clip catch may occur with the B.Braun Infusomat Space infusion pump when the IV set is improperly inserted into the pump and the pump door is forced closed.

Issue 2: If pole clamps with damaged or missing components are used or if the IFU is not followed when securing infusion pumps, there is a risk of detachment. Detachment may result in injury to a user or patient, damage to the pump and delay in therapy. B. Braun issued a poster to customers in February 2010 illustrating correct pole clamp handling. A copy is provided with this safety notice.

If you encounter either of the above issues, please also inform the Irish Medicines Board.

Actions To Be Taken:
Issue 1: In relation to breakage of the anti free-flow clip catch located inside the door of the Infusomat Space infusion pump, the IMB advises that users:

(1) Follow the instructions outlined by the manufacturer in the device Instructions for Use (IFU) for loading and unloading of an infusion set when using the Infusomat Space. Specifically, if the door of the device is difficult to close, check the IV set and anti free-flow clamp (green) for proper installation.

(2) In accordance with the IFU, before opening the door, close the roller clamp and ensure that the door does not fall open completely. If the door opens to a horizontal position, check that the slide clamp (green) is properly occluding the IV set and the door extension hook is not broken.

(3) If the door hook is found damaged or broken, remove the pump from use.

(4) Ensure B. Braun is notified of the issue and arrange with the manufacturer for the device to be repaired appropriately.

Issue 2: In relation to detachment involving the B. Braun Pole Clamp when used to mount Infusomat and Perfusor Space pumps, the IMB advises users:-

(1) When mounting infusion pumps using the B. Braun pole clamp, ensure the pumps are secured in accordance with the manufacturer’s IFU.

(2) Do not use pole clamps which are damaged or missing clamp grids.

(3) Ensure B. Braun is notified of the issue and arrange with the manufacturer for the device to be repaired appropriately.

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
Website: N/A

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
Website: N/A

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 related poster

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