HomeChoice/HomeChoice PRO Automated PD System

Notice type: Advisory

Date: 14/03/2014


Product name or type:
HomeChoice/HomeChoice PRO Automated PD System


Manufacturer Or Supplier:
Baxter Healthcare SA

Target Audience:
Hospital Managers / CEOs 
Risk Managers 
Clinical Directors 
Clinical Engineers 
Nursing Managers 
Nursing staff 
Purchasing Managers 
Hospital personnel 
Palliative Care Units 
Intensive Care Units 
Renal Units 
Anaesthetic Officers 
Accident & Emergency Departments 
Nephrology Departments 
Adult intensive care units 
Day surgery units 
Oncology units 
Paediatric intensive care units 
Neonatal units 
All wards 
General Practitioners 
Healthcare professionals who use these devices 
Healthcare professionals managing patients who use these devices 
General public

Problem Or Issue:
Baxter Healthcare is issuing a Field Safety Notice (FSN) to inform users of the HomeChoice/HomeChoice PRO systems of an additional warning to be included in the device product labeling. The warning relates to unintended Increased Intraperitoneal Volume (IIPV) in specific patient populations using peritoneal dialysis therapy.

Background Information Or Related Documents:
HomeChoice/HomeChoice PRO Automated PD System Document

IIPV is a condition with an unintended excess of fluid in the peritoneal cavity that may become symptomatic, especially in high risk populations. 

Specific populations using Peritoneal Dialysis (PD) therapy such as neonates, infants, small children and any patient with significant heart or lung disease are more vulnerable to the negative effects of excessive retention of fluid in the peritoneal cavity. Overfilling (IIPV) or not draining enough fluid during PD therapy can result in excess fluid in the abdomen accompanied by patient symptoms. 

The additional warning identifies symptoms related to unintended IIPV that may result in these specific populations and provides specific instructions for the patient to follow if IIPV is suspected.

Actions To Be Taken:
1. Follow the manufacturer’s recommendations in the attached FSN. A copy of the FSN (and warning instructions) should be kept with your HomeChoice user manual.

2. Ensure that relevant personnel, in particular home patients, receive a copy of the attached FSN and are made aware of the information contained in the FSN and additional warning instructions. 

3. If you have distributed the devices to other healthcare professionals or organisations, please forward this notice accordingly.

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

Ian Gavigan 
Quality Systems Manager 
Baxter Healthcare Ltd. 
Deansgrange Business Park 
Co. Dublin 

Telephone: +353-1-2065500 
Fax: +353-1-2065577 
E-mail: shs_complaints_dublin@baxter.com 

All adverse incidents relating to a medical device should be reported to the: 

Health Products Regulatory Authority
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 quote IMB reference number V20226 for any queries in relation to this action. 

Please click here to view a copy of the FSN

Please click here to view a PDF version of this Safety Notice

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