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Baxter Coiled Tube Infusors. Priority 2 – Warning

Notice type: Warning

Date: 24/04/2014

  

Product name or type:
Baxter Coiled Tube Infusors. Priority 2 – Warning

Reference:
SN2014(19)

Manufacturer Or Supplier:
Baxter

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:

Following a review of customer complaints for over-infusion, Baxter has identified an error in the Directions For Use for the Coiled Tube Infusor system. As outlined in the attached FSN, direction for use #5 is incorrect for the coiled tube infusor. The nominal (labelled) flow rate is achieved when the Elastomeric Reservoir is positioned 6-8 inches (15-20cm) below the distal luer lock and NOT when positioned at the same height as stated in the directions for use. 

Baxter has indicated that the following products which have been supplied to the Irish market are impacted by this issue. 

Product codes

Product Name

2C1071KJP

Single Day INFUSOR 2 ml/h System

2C1073KJP

Half Day INFUSOR SV 5 ml/h System

2C1080KJP

Multiday INFUSOR 0.5 ml/h System


Background Information Or Related Documents:
Baxter Coiled Tube Infusors. Priority 2 – Warning Document

The direction for use #5 is incorrect for the coiled tube infusor. Delivery of medication at a faster rate than intended may lead to toxicity and changes to efficacy that require medical intervention. 

Baxter will be implementing a revision to the Directions for use to reflect the correct placement of the device for all coiled tube infusors.

Actions To Be Taken:
The IMB advise that users: 

(1) Follow the instructions outlined by the manufacturer in the field safety notice (FSN) attached. 

(2) Forward this IMB Safety Notice to all those within your organisation that need to be aware of this information. Please also pass this Safety Notice and the attached FSN on to any end users or organisations where these devices may have been distributed.

Further Information:
Enquiries to the manufacturer should be addressed to: 

Ian Gavigan 
Quality Systems Manager 
Baxter Healthcare Ltd. 
Deansgrange Business Park 
Blackrock 
Co. Dublin 
Telephone: 01 206 5500 
Fax: 01 206 5577 
E-mail: qa_dublin@baxter.com 


Enquiries to the distributor should be addressed to: 
Ian Gavigan 
Quality Systems Manager 
Baxter Healthcare Ltd. 
Deansgrange Business Park 
Blackrock 
Co. Dublin 

Telephone: 01 206 5500 
Fax: 01 206 5577 
E-mail: qa_dublin@baxter.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

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