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HomeChoice/HomeChoice PRO Automated PD System
Notice type:
Advisory
Date:
14/03/2014
Product name or type:
HomeChoice/HomeChoice PRO Automated PD System
Reference:
SN2014(11)
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
Theatres
All wards
General Practitioners
Healthcare professionals who use these devices
Healthcare professionals managing patients who use these devices
Carers
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
Blackrock
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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Date Printed: 16/04/2024