The US Food and Drug Administration (FDA) has issued a class I recall for the Flow-c and Flow-e anesthesia systems. Getinge, the healthcare company out of Sweden that manufactures the systems, initiated the recall on May 2. Although a class I recall is reserved for only the most serious of product errors, those which might cause injury or death to users, there have been no deaths or injuries associated with use of the system. Instead, this recall was prompted by 21 complaints from customers.
Normally the device functions to provide inhalation anesthesia, help control the breathing of unconscious patients, and help people who have limited ability to breathe. It can be used on everyone from neonatal patients to adults and is only operated in the hospital by trained professionals.
In order to keep airways free for oxygen to flow, the device has a suction unit to remove bodily fluids from the mouth. But an issue with the suction unit of the system has prompted concern, according to the FDA’s announcement. In certain product models, a cracked or broken on/off switch on the suction unit may cause the suction system to falter. This means that phlegm, blood, and stomach contents may not be automatically removed from the patient’s mouth and respiratory tract.
In minor scenarios, this presents a logistical issue for anesthesiologists, who would have to spend time manually sucking out debris from the patient in between procedures. But in more severe scenarios, these fluids can block airways, which may cause choking, loss of oxygen, lung infection, brain injury, or death.
In response to these concerns, the company recommends that users look for the serial numbers on the systems’ product labels. The 58 unique serial numbers to look out for can be found on the FDA’s recall database entry. The products in question were distributed between June 2, 2020 and February 15, 2022.
If a customer discovers they have an affected model, the FDA says it’s safe to continue using the device as long as the user follows daily system checkout and pre-anesthesia checkout procedures, as outlined in the operator’s manual. This includes checking to make sure the suction unit is operable and on/off switches are intact. Users should also keep a backup suction option close by.
Getinge also plans to mobilize maintenance workers to hospitals with affected devices in order to correct the errors. They want customers to know that they can schedule one of these visits by calling the phone number at the bottom of the FDA release. In addition, they should report a faulty device to both the FDA and the company.
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