Safety Alerts

Medical device manufacturer, B. Braun, has issued a medical device safety alert concerning its Infusomat Space [Article Number: 8713050; Serial Number: 867651, 867646, 867710,867654, 867711] [HKMD No.: 200406].

In the course of Post Market Surveillance activities, the manufacturer identified a sporadic occurrence of potentially false down- and upstream pressure alarms which are caused by the upstream occlusion pressure sensor of the Infusomat Space Infusion Pump. Electrostatic interactions are naturally generated during the peristaltic movement of the Infusion Pump. This electrostatic effect may influence the sensor and lead to degradation of the upstream sensor performance over time. The sensor may then stop working after extended periods of operation. The frequency of occurrence depends on the manner in which the devices are handled and the environment. Therefore, not all devices within the identified serial number range exhibit this behavior in actual clinical use.

According to the manufacturer, in clinical practice the following scenarios may occur and may lead to an interruption of the infusion that could result in potential patient risks ranging from no clinical relevance up to serious injury or patients' death:

• Increased number of downstream occlusion alarms with no actual obstruction of fluid flow which cannot be compensated by adjusting the device pressure settings to higher values;
• Higher frequency of upstream alarms, with no actual obstruction of fluid flow in the pump IV set;
• Pump IV-set not accepted when closing the pump door (e.g. when changing the set).

The manufacturer will be exchanging the Upstream Occlusion Sensor built in the mentioned serial numbers of Infusomat Space Infusion Pumps. Affected users should follow the mitigation steps listed on the customer letter issued by the manufacturer.

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

Posted on 15 Aug 2023