My HPRA: Register

pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0 Priority 2 – Warning Caution In Use

Notice type: Advisory

Date: 09/05/2014

   

Product name or type:
pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0

Reference:
SN2014(24)

Manufacturer Or Supplier:
Merck Serono

Target Audience:
All Hospital Staff 
All Nursing Home Staff 
A&E Departments 
Carers 
Chief Executive Officers 
Clinical Directors 
Day Surgery Units 
Emergency Medical Technicians 
Gastroenterology Departments 
General Practitioners 
General Public 
Healthcare professionals who use these devices 
Healthcare professionals managing patients who use these devices 
High Dependency Units 
Hospital Managers 
Hospital Pharmacists 
Intensive Care Units 
Maternity Units 
Midwifery Departments 
Neonatology Departments 
Nursing Managers 
Nursing staff 
Obstetrics and Gynaecology Departments 
Oncology Nurse Specialists 
Paediatric Departments 
Paramedics 
Purchasing / Procurement / Material Managers 
Risk Managers 
Supplies Managers

Problem Or Issue:
A communication issued by Merck Serono to Irish customers in May 2013 indicated that an additional ‘safety feature’ had been introduced for these products, to facilitate their use in non-buffered solutions. 

Merck Serono has informed the Irish Medicines Board (IMB) that the safety feature introduced in 2013 does not function as intended over the lifetime of the product. 

The manufacturer has issued the attached Field Safety Notice (FSN) to users of these devices to reiterate that these devices should only be used with gastric aspirate. Merck Serono is also implementing a revision to the Instructions For Use (IFU) for their pH Indicator Strips in order to strengthen the warning regarding use with low buffered solutions. 

The IMB wishes to remind users to use these devices with caution.

Background Information Or Related Documents:
pH Indicator Strips (non-bleeding) pH 0-6.0 & 2.0-9.0 Document

Concerns have been expressed to the IMB in relation to the performance of Merck Serono pH Indicator Strips (non-bleeding). The IMB wishes to remind users to use these devices with caution. These strips are designed to verify safe nasogastric tube placement by measuring the pH of human gastric aspirate using a colour change reaction. Patient death can occur if a patient is fed using a tube that has been incorrectly positioned in the lung. 

The IFU indicates that these devices are only for use with gastric aspirate.

Actions To Be Taken:
The IMB advises users: 

(1) Merck Serono pH Indicator strips (0-6.0 product code 090120604 and 2.0-9.0 product code 090120603) should be used with caution. 
a. These strips are only for use with gastric aspirate 
b. These strips are not suitable for use with low buffered solutions 
c. These strips are not suitable for use with any kind of water (distilled, sterilised, potable, bottled or tap water) 

(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 on to any end users or organisations where these devices may have been distributed.

Further Information:
Enquiries should be addressed to: 

Merck Serono Ltd 
Bedfont Cross 
Stanwell Road 
Feltham 
Middlesex 
TW14 8NX 
United Kingdom 
Telephone: +44 (0) 208 818 7373 
Fax: +44 (0) 208 818 7263 
E-mail: medinfo.uk@merckgroup.com
Website: www.merckserono.co.uk 

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 copy of the field safety notice

Please click here to view a PDF version of this safety notice

« Back