FDA Flags Cracked Hoses in Disposable Breathing Circuit
核心洞察
The FDA issued an early alert on September 3 for the Draeger VentStar Resus Neo (搜索) breathing circuit, model MP00310, after the manufacturer found the hoses can crack.
Draeger (搜索) told customers on September 1 to inspect each hose before use and discard any with cracks or a detached hose, with no returns required.
The FDA said a cracked hose may leak or fall off, restricting ventilation or delaying therapy and potentially causing hypoxia (搜索) or death, though no serious injuries or deaths were reported as of August 27.
The FDA issued an early alert on September 3 covering the Draeger VentStar Resus Neo (搜索), model MP00310, a disposable breathing circuit that carries breathing gas to infants weighing up to 22 pounds. Draeger (搜索) sent letters to affected customers on September 1 instructing them to inspect each hose before use and discard any showing cracks or a detached hose. Returns are not required. The alert lists a single model and a single device identifier but no affected lot numbers, so the inspection instruction applies to the model as a whole.
Draeger (搜索) said it is aware of cases where users spotted obvious cracks before use, and as of August 27 the company had reported no serious injuries or deaths connected to the problem. The FDA said a cracked hose that is used may fall off or leak, resulting in restricted ventilation or delayed therapy that could lead to falling oxygen levels, hypoxia (搜索), or patient death, which is why the agency flagged the issue as potentially high risk. Reported cases so far involved clinicians noticing cracks before the circuit was used on a patient.
An early alert notifies the public of a potentially high-risk device issue before the FDA completes its review and determines how, or whether, the company's action should be classified. The situation may be upgraded to a classified recall, and the agency said it will update the page as significant new information becomes available. The alert follows other August FDA early alerts covering Hudson RCI neonatal and infant heated wire breathing circuits from Medline, certain ventilators from CooperSurgical (搜索), and certain nitric oxide delivery systems from NOxBOX (搜索). The FDA has not said how many hoses are affected, how widely they were distributed, whether the cracking traces to a specific production period, or whether the action will be classified as a recall, and Draeger (搜索) has not publicly explained the cause.
Source: MedicalDaily