http://bmj.com/cgi/content/full/323/7312/529/a

BMJ 2001;323:529 ( 8 September )

News

Baxter withdraws dialyser after 12 patients die

Xavier Bosch, Barcelona

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 symptomssweating, 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.

© BMJ 2001

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