Liquid test and sudden death in dialysis patients

Jasna Slavicek1 and Lems Jerin2

1 Dialysis Center, UHC Zagreb, Croatia and 2 General Hospital Pula, Croatia Email: jasna.slavicek{at}zg.tel.hr

Sir,

Herewith we would like to refer to the editorial entitled ‘Performance liquid test as a cause for sudden deaths of dialysis patients: perfluorohydrocarbon, a previously unrecognized hazard for dialysis patients' by Canaud and the panel of experts, published in the April 2002 issue of Nephrology Dialysis Transplantation, reporting on tragic events related to the use of A (Althane) series of Baxter dialyzers [1].

In this editorial, Canaud tries to distribute the responsibility for these tragic events at three levels:

  1. the dialyzer manufacturer (Baxter),
  2. the level of the regulatory notified body (TÜV),
  3. the level of the user (dialysis unit).

Concerning the last one, he stated that dialyzer priming and cleaning procedures had probably not been done properly.

At the UHC Zagreb Dialysis Center, five patients dialysed on Baxter's dialyzers died over 4 days [2]. The dialysis centre has existed for over 30 years and has cared for 120 chronic haemodialysis patients, 42 chronic peritoneal dialysis patients and over 400 kidney transplant recipients. The personnel are highly qualified and experienced and perform their duties very conscientiously. Dialyzer rinsing and priming have always been performed strictly according to the manufacturers' instructions. The same is true for Pula Dialysis Center and for four other dialysis centres in Croatia, in which a total of 23 regular dialysis patients who were treated with Baxter dialyzers died. In all these centres, dialyzers are rinsed strictly according to the manufacturer's instructions. Perfluorocarbon is intensely hydrophobic and completely insoluble in water according to the manufacturer's data sheet [3], hence physiological salt solution rinsing is ineffective. Accordingly, the standard rinsing procedure cannot remove PF 5070 remaining after air rinsing. From all the above it follows that the dialysis staff can by no means be considered responsible for the described patient deaths. This must be clearly and openly said. It is true that Canaud apologized in the Nephrology Dialysis Transplantation September 2002 issue [4], although rather vaguely. The emphasis should, however, be placed on the manufacturer's responsibility in product quality control as well as on the manufacturer's obligation to report every change in the production process to a European notifying authority such as the TÜV as well as the FDA. Finally, filter repairing as such should be banned.

References

  1. Canaud B. On behalf of the European Experts Panel. Performance liquid test as a cause for sudden deaths of dialysis patients: perfluorohydrocarbon, a previously unrecognised hazard for dialysis patients. Nephrol Dial Transplant 2002; 17:545–554[Free Full Text]
  2. Material Safety Data Sheet: PF5070 3M Brand Performance fluid. Minnesota Mining and Manufacturing Company, St Paul Minnesota1999.
  3. Slavicek J, Glavas Boras S, Smalcelj R et al. Sudden death in chronic hemodialysis patients caused by dialyzer. Nephrol Dial Transplant 2002; 17 [Suppl 1]:293[CrossRef]
  4. Canaud B. Performance liquid test as a cause for sudden deaths of dialysis patients. Nephrol Dial Transplant 2002; 17:1706–1707[Free Full Text]




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