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Kryo range of freezers. Priority 2 – Warning

Notice type: Advisory

Date: 06/05/2014

  

Product name or type:
Kryo range of freezers. Priority 2 – Warning

Reference:
SN2014(23)

Manufacturer Or Supplier:
Planer plc

Target Audience:
All Hospital Staff 
Laboratory Staff 
Chief Executive Officers 
Healthcare professionals who use these devices 
Hospital Managers 
Purchasing / Procurement / Material Managers 
Risk Managers 
Establishments authorised for the processing of blood, tissues and cells

Problem Or Issue:
Should the temperature probe to the chamber fail in a short circuit condition, the temperature will appear to be too cold, and the controller will attempt to compensate by warming the samples. Although this behaviour is the expected response of the control system, two software changes have been released to improve the resilience of the freezer systems to temperature probe faults. Planer has released new versions of the PID Engine firmware, PP007951 v6.85 and the MRV main application, CFG007954 v5.22.

Background Information Or Related Documents:
Kryo range of freezers. Priority 2 – Warning Document

Planer plc has issued a field safety notice relating to certain models of the Kryo range of controlled rate freezers. Such freezers are used to gradually freeze tissues and cells in the presence of cryoprotectants, in accordance with a programmed protocol. The models identified in the field safety notice are as follows: 

• Kryo 1060-180 
• Kryo1060-380 
• Kryo3xx-1.7 
• Kryo5xx-16 
• Kryo750Plus 
• MRV Controller, and 
• Kryo-250 

The IMB is working to ensure that all establishments which may cryopreserve tissues and cells using a controlled rate freezer are aware of the field safety notice.

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: 

Service Manager 
Planer plc, 
110 Windmill Road, 
Sunbury on Thames 
Middlesex, TW167HD
UK 
Telephone: +44 1932 755036 
Fax: N/A 
E-mail: service@planer.com 
Website: N/A 

Enquiries to the manufacturer should be addressed to: 
(alternative contact details) 
Quality Manager 
Planer plc, 
110 Windmill Road, 
Sunbury on Thames 
Middlesex, TW167HD
UK 
Telephone: +44 1932 755072 
Fax: N/A 
E-mail: quality@planer.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 download a copy of this safety notice

Please click here to download copy of the field safety notice

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