Alerta De Seguridad para Infinity Acute Care System Monitoring Solution using with DualHemo Mcable

Safety alert

2012-11-29

2012-11-29

Hong Kong

DH

https://www.mdco.gov.hk/english/safety/recalls/recalls_20121129.html

Medical device safety alert: draeger medical infinity acute care system monitoring solution using with dualhemo mcable medical device manufacturer, draeger medical, has issued a medical device safety alert regarding infinity acute care system (iacs) with dualhemo mcable. the manufacturer was informed that the displayed value for the invasive blood pressure measurement of the iacs was lower than the actual patient values were. in one of the cases the user started an incorrect patient therapy because of the indicated too low pressure. no patient injury has been reported in relation to these four cases. investigations on this topic have shown that liquid ingress in the cable connection of the dualhemo mcable may cause inaccurate measurements. further investigation revealed that this can happen if the dualhemo mcable is used in a non-vertical position or vertically but top down instead of top up, or if it is simply laid down on the floor or on the patient bed and is not adequately positioned. the instructions for use (ifu) of the iacs does identify that the dualhemo mcable should be positioned in a vertical orientation. however, it does not describe what is meant by the term vertical. vertical is intended to mean that the dualhemo should be hung on a pole with the two mcables pointed toward the floor. the dualhemo contains an integrated clip on the single cable that is intended to facilitate proper placement and orientation of the dualhemo pod. the manufacturer has developed an amendment for the ifu describing the correct handling of the dualhemo mcable supported by graphics. draeger advises all affected users to add the amendment to their ifu. according to the local supplier, the affected products were distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 29 november 2012.