| Developers: | Hillrom, Baxter International |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2024: Recall of defective equipment that suddenly shuts down during operation
On June 26, 2024, the US Food and Drug Administration (FDA) announced the recall of the defective Baxter Life2000 ventilators. The detected defect can lead to a sudden shutdown of the device during operation.
The compact Life2000 system is designed to provide respiratory support to patients at home or on the road. Thanks to the Breathe Pillows interface, the use of a mask is not required: this allows you to talk, eat and drink freely while using a ventilator. Various air supply modes are available: rest, moderate or high activity levels. The system is suitable for people who have chronic respiratory failure due to COPD, suffer from neuromuscular diseases or limited thoracic disorders (for example, kyphoscoliosis), prepare for or recover from lung transplantation.
Life2000 devices can be powered by a battery module that lasts 6 hours of normal use. The detected problem is associated with damage to the charging unit, due to which it is impossible to stably replenish the battery energy reserve. This can lead to impaired or complete cessation of ventilation, which poses a threat to the health and life of patients.
More than 2500 Life2000 devices are subject to recall. The manufacturer recommends that patients using this system have a spare ventilator or other oxygen device ready for use. The FDA has given the defect a maximum hazard rating: meaning the devices can cause patients "serious injury or death. Fatal cases associated with the problem were not recorded as of early July 2024.[1]
2023: Equipment scrap
On March 10, 2023, Baxter International reported a defect in breathing equipment. Marriage leads to insufficient oxygen saturation of the blood, which can result in irreversible consequences for patients and even death.
The problem affects the Life 2000 breathing apparatus manufactured by Hillrom, which Baxter acquired at the end of 2021 for about $10.5 billion. The portable device is designed to support patients' breathing at home. It does not require a mask, and the battery charge lasts for about six hours of operation. The device weighs less than 500 g; during wearing, it can be fastened, for example, on a belt.
As reported in a notice on the website of the US Food and Drug Administration (FDA), problems with the use of Life 2000 can be observed if the device is connected to a third-party oxygen concentrator. A lack of oxygen can occur if the hoses of the system are bent, there is too much moisture in them, or they have been modified in some way.
Low blood oxygen saturation can reportedly lead to symptoms such as shortness of breath, confusion, palpitations or bluish skin. Moreover, the problem can provoke severe irreversible consequences or death. Cases of hospitalization of patients due to this defect are known, but fatal episodes have not been reported.
The FDA notice says patients can continue to use the Life 2000 machine, subject to system review recommendations and preventive care requirements. Baxter said it was monitoring the situation and exploring possible ways to address the problem.[2]
Notes
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