Medical device manufacturer, Philips Healthcare, has issued a medical device safety alert concerning its IntelliSpace Critical Care & Anesthesia Clinical Information System. The affected devices are identified as follows:-

• 865047 IntelliVue Clinical Information Portfolio (ICIP), Rev D
• 865209 IntelliVue Clinical Information Portfolio (ICIP), Rev E
• 866072 IntelliSpace Critical Care & Anesthesia (ICCA), Rev. F
• 866148 IntelliSpace Critical Care & Anesthesia (ICCA), Rev. G

According to the manufacturer, a software configuration defect has been identified that impacts one Standard Content (configuration that is shipped with the product) unit of measure (gm/m2). The defect involves an incorrect multiplier in the configuration that causes an incorrect calculation of medication dosage. The error could result in a calculated dose that is 10 times the correct dose. If the user does not identify that an incorrect multiplier exists in the Standard Content, a patient may receive a dose of medication that is incorrect (10 times the intended dosage).

Users are advised to implement the instructions outlined in the Mandatory Field Change Order (FCO) if the Body Surface Area (BSA) (gm/m2) Standard Content is used in the configuration. The manufacturer has initiated a correction to address this issue and a manufacturer's representative will contact users to schedule the implementation of this correction.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of the affected products, please contact your supplier for necessary actions.

Posted on 28 November 2014