Customers who received the products were notified "to immediately cease using them, quarantine any inventory, and arrange for their return to GAMBRO Healthcare."
"A total of four patient deaths have been reported following dialysis treatment," the press release wrote. "Symptoms reported include abdominal pain, nausea, vomiting, cyanosis, chest pain, and flushing that occurred during and/or following dialysis treatment," it warned.
The tubing was manufactured in Tijuana, Mexico, according United Press International, and as many as 6,000 sets of tubing may have been shipped.
In another product malfunction, on August 16, 2005, Gambro issued a "Worldwide Safety Alert" to all users of its Prisma System dialysis machine explaining what actions to take to reduce the problems with the device that resulted in excessive fluid removal.
The Prisma System is specially designed to perform the complete range of continuous renal replacement therapy for critically ill patients in the intensive care unit.
In this country, the FDA now says nine deaths and 11 serious injuries have been linked to the Prisma System. Since the device was introduced in 1997, approximately 1,900 units have been distributed to facilities in the US, and about 5,000 were sold worldwide. The system serves about 80% of the market for acute dialysis care in this country.
On January 5, 2006, Gambro Dasco, SpA, a production unit located in Italy, received a warning letter from the FDA reflecting continued concerns about the safety, adequacy and effectiveness of Gambro renal systems. The FDA also issued an import ban, calling for the detention of all Gambro's dialysis machines shipped from Italy until the issues are resolved.
In addition to the Prisma, the ban covers the Phoenix machine, used in outpatient dialysis care, and the company's newest product the Prismaflex machine, which is said to be an improved version of the Prisma System.
That letter arrived shortly after the FDA sent a 13-page report to Gambro following a September 2005, inspection of the company's plant in Italy where the Prisma System is produced. The report listed numerous violations at the plant, and said more than 90 incidences of serious problems with the device, had been reported to Gambro but had not been reported to the FDA, including deaths. The report specifically noted Cambro's:
1. Failure to submit reports to FDA after receiving information that reasonably suggested that one of your marketed devices may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:
a) A patient died on June 6, 2004, two days after the Prisma removed 100 cc too much fluid from the patient. This event should be reported as a device-related death.
b) A facility reported that a Prisma contributed to the death of a patient on November 20, 2004, after multiple alarms for air in the blood and a blood leak. This event should be reported as a device-related death.
The report also lists more than 17 events that should have been reported under serious injuries.
Until recently, Gambro claimed user error was the sole cause of the problems with the Prisma system. However, in a letter to renal caregivers in January 2006, the company's medical director, Juan Bosch, MD, acknowledged that software glitches might be giving users incorrect readings on fluid removal.
On February 27, 2006, the FDA sent another letter to all Renal Dialysis Caregivers, stating: "The FDA has become aware of additional serious injuries and deaths associated with the use of the Gambro Prisma ® Continuous Renal Replacement Therapy (CRRT) device since the release of our preliminary Public Health Notification in August 2005."
"We want to emphasize again that special caution must be used when operating the Prisma ® System to prevent excessive fluid removal from patients," the agency wrote.
"A total of four patient deaths have been reported following dialysis treatment," the press release wrote. "Symptoms reported include abdominal pain, nausea, vomiting, cyanosis, chest pain, and flushing that occurred during and/or following dialysis treatment," it warned.
The tubing was manufactured in Tijuana, Mexico, according United Press International, and as many as 6,000 sets of tubing may have been shipped.
In another product malfunction, on August 16, 2005, Gambro issued a "Worldwide Safety Alert" to all users of its Prisma System dialysis machine explaining what actions to take to reduce the problems with the device that resulted in excessive fluid removal.
In this country, the FDA now says nine deaths and 11 serious injuries have been linked to the Prisma System. Since the device was introduced in 1997, approximately 1,900 units have been distributed to facilities in the US, and about 5,000 were sold worldwide. The system serves about 80% of the market for acute dialysis care in this country.
On January 5, 2006, Gambro Dasco, SpA, a production unit located in Italy, received a warning letter from the FDA reflecting continued concerns about the safety, adequacy and effectiveness of Gambro renal systems. The FDA also issued an import ban, calling for the detention of all Gambro's dialysis machines shipped from Italy until the issues are resolved.
In addition to the Prisma, the ban covers the Phoenix machine, used in outpatient dialysis care, and the company's newest product the Prismaflex machine, which is said to be an improved version of the Prisma System.
That letter arrived shortly after the FDA sent a 13-page report to Gambro following a September 2005, inspection of the company's plant in Italy where the Prisma System is produced. The report listed numerous violations at the plant, and said more than 90 incidences of serious problems with the device, had been reported to Gambro but had not been reported to the FDA, including deaths. The report specifically noted Cambro's:
1. Failure to submit reports to FDA after receiving information that reasonably suggested that one of your marketed devices may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1). For example:
a) A patient died on June 6, 2004, two days after the Prisma removed 100 cc too much fluid from the patient. This event should be reported as a device-related death.
b) A facility reported that a Prisma contributed to the death of a patient on November 20, 2004, after multiple alarms for air in the blood and a blood leak. This event should be reported as a device-related death.
The report also lists more than 17 events that should have been reported under serious injuries.
Until recently, Gambro claimed user error was the sole cause of the problems with the Prisma system. However, in a letter to renal caregivers in January 2006, the company's medical director, Juan Bosch, MD, acknowledged that software glitches might be giving users incorrect readings on fluid removal.
On February 27, 2006, the FDA sent another letter to all Renal Dialysis Caregivers, stating: "The FDA has become aware of additional serious injuries and deaths associated with the use of the Gambro Prisma ® Continuous Renal Replacement Therapy (CRRT) device since the release of our preliminary Public Health Notification in August 2005."
"We want to emphasize again that special caution must be used when operating the Prisma ® System to prevent excessive fluid removal from patients," the agency wrote.
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