PLEGIOX Cardioplegia Heat ExchangerAll Standalone PLEGIOX Cardioplegia Heat Exchangers and those included in tubing sets. 의 리콜

Recall

RC-2017-RN-00978-1

Class I

2017-08-08

Australia

DHTGA

https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00978-1

The plegiox heat exchanger is used to set and maintain the temperature (for given flow rates and within the given temperature range) of blood cardioplegia and / or crystalloid cardioplegia solutions during extracorporeal circulation. the plegiox heat exchanger consists of two liquid circulations strictly separated from each other by a separating barrier to separate both liquids from each other and to effect thermal transfer at the same time; the design of the plegiox uses hollow fibres made of polyurethane. hollow fibres serve as barrier separating the circulating liquids while effecting thermal transfer. maquet cardiopulmonary gmbh (mcp) internal investigations have revealed that the specification of the performance factor (pf) at flow rates of 1 litre per minute is not always maintained as defined in instruction for use (ifu). deviations up to minus 20% were identified during in-house testing. zero adverse events have been reported in relation to this insufficiency.

Getinge seeks to notify users that: When using the PLEGIOX, the flow rate should be no higher than 500 ml/min to ensure reasonable performance.