B. Braun Medical’s recall of Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, and Non-Wireless BATTERY PACK because of faulty occlusion alarms have been classified by the US Food and Drug Administration (FDA) as Class 1, which is the most severe kind of recall.
The Infusomat Space Volumetric Infusion Pump System, which includes the Infusomat Space Large Volume Pump, Wireless and Infusomat Space Large Volume Pump, and BATTERY PACK, are designed for use on adults, paediatrics, and newborns.
They are intended to be used by healthcare experts in healthcare facilities for the intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products.
As per the American health regulator, the use of these devices can lead to serious injuries or death.
In few models, an occlusion alarm can sound when there is no occlusion, triggering the pump to stop delivering medications, including high-risk ones like vasopressors, to the patient.
When high-risk drug infusions are interrupted, haemodynamic instability may result, necessitating medical attention to avoid irreversible damage to bodily tissues or functions.
This could pose a threat to life or even result in death in certain situations, the FDA said.
There have been 51 complaints, one reported injury, and one documented death pertaining to the use of the recalled products.
The model numbers of the recalled devices are 8713051U and 8713052U which were distributed between 26 October 2022, to 17 July this year.
B. Braun Medical has recalled 10,655 devices since it was initiated on 21 September 2023.
FDA said that people who need intermittent or continuous delivery of parenteral fluids, medications, blood, and blood products are at potential risk.
The devices can also affect healthcare personnel engaged in these procedures.
The mmedical device firm issued an Important Medical Device Advisory and requested customers to use the device for only low-risk medication and avoid high-risk medications.
In addition, the company will contact clients and send experts to swap out the occlusion pressure sensors with a second source of qualified sensors.
