Gambro's Hemodialysis products are allegedly susceptible to bacterial growth, device malfunctions, and user errors which can cause severe, sometimes fatal side effects in humans. Several reports of patients dying or experiencing high fever or stroke after kidney dialysis with use of Gambro machines concerns professionals.
Hemodialysis machines are used in the renal dialysis process for processing a patient's blood to remove waste from the body when the kidney no longer functions properly. Hemodialysis machines clean the blood and monitor the procedure and rate of flow. Hemodialysis can be performed in a hospital, in a special facility, or even at home.
Hemodialysis RecallIn November 2005, the FDA announced a Class 1 Recall of the Gambro Prisma Renal Replacement system (Model numbers: 018080100, 018080101, 018080001D).
Gambro issued a warning to health care providers and will offer training regarding the Prisma's functioning. Apparently, the system's alarm would sound and continue to remove or deliver an excessive amount of fluid to/from the patient unless the caregiver quickly identifies and resolves the problem
According to the FDA warning letter, "If treatment is continued without resolving the cause of these alarms, excessive fluid may be removed from the patient, and this can result in serious injury or death. Device design issues may also be contributing to the problem, and this is currently under investigation by both the FDA and the firm [Gambro]."
After investigation, the FDA notes 9 deaths and 11 serious injuries associated with the Prisma System.
Other Gambro Hemodialysis products include the Phoenix System with Diascan or Exalis Dialysis Management Tool and various blood pressure cuffs, blood pressure monitor tools, waste management systems, data collection systems, and medical pumps.
Bacterial InfectionAnother concern with hemodialysis medical devices is the risk of bacteria. Allegedly, bacteria can grow on the thin hemodialysis filter or dialyzer which can play a part in generating or spreading disease. Many parts of a dialysis machine are disinfected and reused but certain bacterial strains can form a biofilm which can mutate and withstand disinfection. In order to prevent bacteria from spreading, dialysis machines and parts need to be properly sterilized.
Bacteria found on dialysis machines has been linked to pneumonia, chronic inflammation, HIV and other diseases.
Gambro Renal Products in the NewsGambro is a worldwide medical technology company with annual revenues of $2 billion. Gambro's Renal Products are a major business group of this company. Recently, Gambro has developed key agreements with Baxter and DaVita to increase distribution of their hemodialysis products.
FDA regulators are discussing keeping Bextra, Pfizer Inc.'s pain drug off the The Gambro website claims that in January 2006, their Renal Products unit received a warning letter from the FDA blocking the importation of kidney dialysis monitors after a failed inspection at their Medolla, Italy manufacturing facility. The banned dialysis monitors include: Prisma, Prismaflex and Phoenix. (Jan-16-06) [IN-PHARMA TECHNOLOGIST]
FDA announces a Class 1 Recall of the Gambro Prisma Renal Replacement system. (Feb-27-06) [FDA]