Background: Hemolysis associated with hemodialysis is rare. The most frequent causes of hemodialysis-associated hemolysis are chemical contamination, heat, or mechanical injury of erythrocytes from occluded or kinked hemodialysis blood lines. When patients in three states developed hemolysis while undergoing hemodialysis between May 13 and 23, 1998, an investigation was initiated.
Methods: A case-patient was defined as any patient at healthcare facilities A (Nebraska), B (Maryland), or C (Massachusetts) during May 13 through 23, 1998 (epidemic period), who had hemolysis diagnosed > or =48 hours after undergoing hemodialysis. To identify case-patients and to determine background rates, the medical records of patients from facilities A, B, and C who were undergoing hemodialysis during the epidemic and pre-epidemic (that is, May 5 through 19, 1998) periods were reviewed. Experiments simulating hemodialysis with the same lot numbers of hemodialysis blood tubing cartridge sets used on case- and control-patients were conducted.
Results: The rates of hemolysis among patients at facilities A, B, and C were significantly higher during the epidemic than the pre-epidemic period (13 out of 118 vs. 0 out of 118, P < 0.001; 12 out of 298 vs. 0 out of 298, P = 0.001; and 5 out of 62 vs. 0/65, P = 0.03, respectively). All case-patients had hemolysis. Twenty (66%) had hypertension. Eighteen (60%) had abdominal pain, and 10 (36%) were admitted to an intensive care unit. There were two deaths. The only commonality among the three outbreaks was the use of the same lot of disposable hemodialysis blood tubing from one manufacturer. Examination of the implicated hemodialysis blood tubing cartridge sets revealed narrowing of an aperture through which blood was pumped before entering the dialyzers. In vitro experiments with the hemodialysis blood tubing revealed that hemolysis was caused by increased pressure on erythrocytes as they passed through the partially occluded hemodialysis blood tubing.
Conclusions: Our investigation traced the multiple hemolysis outbreaks to partially occluded hemodialysis blood tubing produced by a single manufacturer. On May 25, 1998, the manufacturer issued a voluntary nationwide recall of the implicated lots of hemodialysis blood tubing cartridge sets.