Medical device manufacturer, Dräger Medical Systems, Inc., has issued a safety alert concerning its Dual Hemo MCable pod used with the Infinity Acute Care System (IACS) Monitoring Solution.
The manufacturer has determined through internal testing that Dual Hemo MCable Pods with Revision Index (RI) 15 and 16, which are used with the Dräger Infinity Acute Care System, may permit liquid ingress inconsistent with their IPX4 rating, which could potentially result in an incorrect measured value of invasive blood pressure.
The manufacturer has not received any complaints and is not aware of any negative patient consequences arising from this issue. Revisions prior to RI 15, with proper Orientation will still maintain its designated IPX1 rating and are not within the scope of this safety notice. In addition, revisions labelled RI 17 and greater are not affected by this notice because these revisions continue to meet the IPX4 Standard.
Affected users are requested to take the following actions:
According to the local supplier, the affected product is distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 3 October 2017