| Developers: | Fresenius Medical Care (Fresenius Medical Kea) |
| Date of the premiere of the system: | February 2019 |
| Branches: | Pharmaceuticals, Medicine, Healthcare |
Content |
2023: Recall of defective equipment - it causes liver problems and infertility in patients
On October 24, 2023, the U.S. Food and Drug Administration (FDA) announced a recall of hemodialysis equipment manufactured by Fresenius Medical Care. The use of defective devices can result in serious health problems in patients, including infertility.
The hemodialysis procedure is used to remove toxic metabolic products from the body and normalize water balance in patients with acute and chronic renal failure. The problem identified in Fresenius Medical Care equipment is that patients may be exposed to non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), which are leached from some silicone tubes treated with chlorine peroxide.
Adverse effects associated with the use of defective devices can occur several months and even years after the hemodialysis procedure. Such side effects include endocrine dysfunction, liver problems, neurobehavioral changes, skin problems (acne, rash) and male infertility. As of the end of October 2023, deaths provoked by defective equipment were not recorded.
The recall includes Fresenius Medical Care devices of the 2008T family, distributed from August 21, 2008 to June 6, 2022. In total, more than 200 devices supplied, in particular, to the American market are affected. Health care facilities that use defective equipment can contact Fresenius Medical Care for free marriage resolution. The manufacturer emphasizes that in devices that were purchased after October 2022, the problem was initially fixed.[1]
2019: Announcement
On February 11, 2019, Fresenius Medical launched the 2008T BlueStar hemodialysis machine on the market. The new equipment has received more than 30 improvements from its predecessor, company officials said.
Fresenius Medical said the new system should make it easier to operate and maintain the device. Users can receive notifications about the upcoming inspection deadlines, which remind them of the need to carry out preventive maintenance and replace the filter. In addition, a number of new automated technologies were implemented in the new model, including auto-start and auxiliary reinfusion functions. The device can also go into standby mode, reducing dialysate and water consumption. In this mode, the dialysate flow rate is 100 ml/min instead of the usual 300 ml/min.
In addition, 2008T BlueStar has a pH self-monitoring function and maintains electronic patient records and a disinfection log that provides rapid access to data on the latest 1,200 disinfection activities. Independent self-testing of conductivity and pH eliminates the need for an external meter and consumables to assess electrical conductivity. Also, the new system is equipped with an automatic disinfection function that provides more control than current methods. The user can independently set the disinfection time and change it daily if necessary.
Also, the new device provides advanced treatment options that meet the needs of the patient. Low-volume therapy will allow patients weighing 20-40 kg to perform the procedure, and slow low-effective prolonged hemodialysis (SLED) supports patients with acute renal failure, providing continuous dialysis for 12 hours.[2]
Notes
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