Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
Medical device manufacturer, Baxter Healthcare issued a medical device safety alert concerning its PrisMax V3, Rest of World (ROW) [Product Code: 955725] and PrisMax, V2 ROW [Product Code: 955558] [HKMD No.: 200109].
The manufacturer is issuing an Urgent Medical Device Correction for the PrisMax System due to software anomalies occurring during use. If the operator initiates therapy by entering a value other than the default value for the patient Gain/Loss Limit or the Return Pressure Drop Limit (RDL) and uses the Same Patient function, the PrisMax System will return the patient Gain/Loss Limit or the RDL to the default value, rather than the non-default value entered at the initiation of treatment. The PrisMax System interface will display the original values once treatment is restarted but does not have an alert to inform the user of the change. The RDL value will be returned to the original value immediately upon selecting the Same Patient function. The Gain/Loss Limit value will be returned to the original value when the patient weight and/or hematocrit is changed during treatment. These anomalies only occur if the Same Patient function is used when changing the disposable set.
The maufacturer will be upgrading the software on all affected PrisMax units to resolve these anomalies.
According to the local supplier, the affected devices are distributed in Hong Kong.
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 23 Mar 2022