Level 1® Normothermic IV fluid administration sets for use with the Level 1® fast flow fluid warmer units 에 대한 현장 안전성 서한

Field Safety Notice

SN2011(05)

2011-04-08

Ireland

HPRA

http://www.hpra.ie/homepage/medical-devices/safety-information/safety-notices/item?t=/level-1-normothermic-iv-fluid-administration-sets-for-use-with-the-level-1-fast-flow-fluid-warmer-units&id=f797f825-9782-6eee-9b55-ff00008c97d0

Smiths medical has become aware of an increased trend in reports of kinking of the tubing on certain level 1® normothermic iv fluid administration sets (models di-65hl, di-75 and di-150). in some cases, the kink may lead to a decrease in the flow of fluid to the patient. a reduction in flow rate may lead to a delay of therapy, which could result in patient injury.

The Irish Medicines Board advises users of this product to inspect their inventory and segregate the affected products for return to the manufacturer as per the attached field safety notice.  Users should exercise extreme caution when using the alternative replacement products and remain cognisant of the clinical risks associated with these sets, which are not equipped with the F-50 Gas Vent Filter Assembly.  Users should also take care to:  • Ensure that all Level 1® fast flow fluid warmer units contain a copy of the quick reference guide distributed by Smiths Medical in 2007.  • Contact the manufacturer to request a copy of the quick reference guide if required.