http://bmj.com/cgi/content/full/323/7312/529/a
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News
Baxter withdraws dialyser after 12 patients die
Xavier Bosch
The deaths, in 15 days, of 12 patients receiving haemodialysis in
three Spanish hospitals has led the Spanish health ministry to
withdraw two batches of a membrane dialyser.
To date, no direct relation has been proved between the deaths and the
dialyser, made by Baxter Althin Medical, a Swedish subsidiary of the
US manufacturer of medical devices Baxter International. The dead
patients, however, had all been given the same membrane batch.
Between 15 August and 29 August six patients died in the Virgen
del Consuelo Clinic in Valencia, four in the Princesa Hospital in
Madrid, and two in the Hospital Clinic, Barcelona. All of them had
had haemodialysis with the same batch of the cellulose acetate Althane
A-18 dialyser, which had started being used a few days earlier in
the renal units of the three centres.
In the Valencia centre three patients died on the same day, 29 August.
The Princesa Hospital said it told Baxter on 17 August that three
deaths had occurred within three days and that the company should
check the haemodialysis equipment. A few days later Baxter responded
that the equipment was not faulty.
Shortly afterwards the Princesa Hospital learned that patients who had died
in the Valencia centre had received the same batch. The centre then
informed the health ministry, which, on 31 August, stopped
distribution of the potentially contaminated batch as a
precautionary measure.
In a statement on 30 August, Baxter said that the dialyser had no
abnormalities. "To date, there is no evidence associating Baxter
products with the deaths," it said. It also stated that it had
recalled the batch voluntarily that day as a precaution.
But José Luis de Sancho, from the health ministry, said Baxter recalled the
batches because the ministry ordered the company to do so on
30 August. He added that all patients had similar symptoms
sweating, fatigue, nausea, vomiting, and, in
general, a presyncopal state.
Luis Medina, Baxter's spokesman in Spain, said: "To date we have not
detected any abnormality in our filters."
He added that the company had conducted tests on toxicity, haemolysis, and
pyrogenes, all of which were normal, but other tests had yet to be
concluded, such as the quality of water, dialysis concentrates,
drugs administered before and after the dialysis, and the dialysis
machines.
He rejected the possibility that the deaths were due to hypersensitivity, as
some patients died several hours after the end of the haemodialysis
treatment. Such reactions usually appear shortly after starting it,
he said.
He said that the three deaths on the same day could be an "unfortunate
coincidence."
Hospitals in Sweden and Finland had the same batch but managed to track them
down before they were used. Two hospitals in England use the
product, but neither received that batch.
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