FROM MAY 13 through May 23, 1998, a total of 30 patients in three states* developed hemolysis with or without chest pains, shortness of breath, nausea, or abdominal pain while undergoing hemodialysis (HD). Two patients died. This report summarizes the preliminary findings of investigations in Nebraska and Maryland and implicated lot number 04015309 of Cobe Centrysystem 3 Blood Tubing sets (Gambro Healthcare, Lakewood, Colorado)† as the cause of these reactions.
A case was defined as hypertension (an increase of ≥30 mm Hg from the baseline systolic blood pressure) and evidence of hemolysis (i.e., positive "pink test" [pink-appearing serum]) in a patient within 12 hours of initiating hemodialysis during May 13-20. A total of 13 (11%) of 118 patients at two HD centers in Lincoln, Nebraska, had illnesses that met the case definition. In addition, case-patients reported chest pain (five), shortness of breath (four), nausea (four), abdominal pain (four), vomiting (three), back pain (two), cyanosis (two), or diarrhea (one). Onset of symptoms occurred a median of 120 minutes (range: 20-272 minutes) into the dialysis session.
Case-patients ranged in age from 46 to 84 years (median: 70 years); seven were men. They had received hemodialysis for a median of 3 years (range: <1 to 8 years); 11 (85%) used reprocessed dialyzers. Of the 13 patients, 11 (85%) required hospitalization; four (31%), admission to an intensive-care unit (ICU); and three (23%), blood transfusion. The 13 case-patients were dialyzed on 12 different machines but all may have been dialyzed using a Cobe Centrysystem 3 Blood Tubing Set (lot number 04D15309) that was present at the clinic during the dialysis period. During hemodialysis, lot numbers of blood tubing are not routinely recorded. However, for six case-patients, the blood tubing lot number was 04D15309.
Examination of the implicated blood tubing revealed narrowing of the aperture through which blood was pumped during the dialysis treatment. Analyses of the water supply at one of the HD centers was within normal limits for chlorine, chloramine, endotoxin, bacteria, and trace element levels as set by the American Association for the Advancement of Medical Instrumentation.
During May 18-23, a total of 12 (4%) of 298 patients at four HD centers in Baltimore developed abdominal pain (eight), nausea (seven), and/or erythroderma (four); all had evidence of hemolysis on admission to the hospital. Onset of symptoms occurred a median of 114 minutes (range: 22-227 minutes) into the dialysis session.
Case-patients ranged in age from 48 to 85 years (median: 67 years); seven were men. Case-patients had received hemodialysis for a median of 3 years (range: 1 to >5 years); none used reprocessed dialyzers. All case-patients required hospitalization; four, admission to ICU; and six, blood transfusion. The 12 case-patients were dialyzed on 12 different machines, but all may have been dialyzed using a Cobe Centrysystem 3 Blood Tubing Set (lot number 04D15309) that was present at the clinic during the dialysis period.
On May 25, the manufacturer issued a voluntary nationwide recall of specific lots of catalog number 003210-500 (including lot number 04D15309) of Cobe Centrysystem 3 Blood Tubing sets. On June 10, following additional reports (including two additional deaths) in Alabama and New Jersey, the manufacturer expanded the recall to all lots of Cobe Centrysystem 3 Blood Tubing sets and Cobe Hemodialysis kits containing blood tubing sets for dialysis with catalog numbers 003109-400, 003109-410, 003110-500, 003111-500, 003112-500, 003113-500, 003114-500, 003210-500, 003212-500, 003101-000, and 003212-515.
L Spry, MD, A Stivers, Dialysis Center of Lincoln, Lincoln; R Morin, MD, Bryan Memorial Hospital, Lincoln; T Timmons, S Weaver, C Douglas, Lincoln-Lancaster County Health Dept, Lincoln; T Safranek, MD, State Epidemiologist, Nebraska Health and Human Svcs System. J Roche, MD, C Groves, MS, D Portesi, MPH, M Hawkins, MD, D Dwyer, MD, State Epidemiologist, Maryland Dept of Health and Mental Hygiene. Center for Devices and Radiologic Health, and Office of Regulatory Affairs, Food and Drug Administration. Div of Chronic Disease Control and Prevention, National Center for Chronic Disease Prevention and Health Promotion; International Emergency and Refugee Health Program, National Center for Environmental Health; Hospital Infections Program, National Center for Infectious Diseases; and EIS officers, CDC.
In the United States, approximately 225,000 persons with end stage renal disease undergo long-term hemodialysis each year.1 Hemolysis (i.e., premature breakdown of red blood cells [RBCs]) associated with hemodialysis is rare.2,3 The most frequent causes of hemodialysis-associated hemolysis are increased chloramine in the water used for dialysis; nitrate contamination of the dialysate, formaldehyde residue left after dialyzer reprocessing or water treatment system disinfection, use of hypotonic dialysate or dialysate exceeding 108 F (42 C), or mechanical injury of RBCs from occluded or kinked hemodialysis blood lines.2- 4
In this outbreak, all episodes of hemolysis have been associated with blood tubing produced by a single manufacturer. Preliminary findings suggest that the narrowed aperture of the blood tubing sets caused mechanical lysis of the RBCs.
To ascertain the extent of this problem, all episodes of hemolysis in dialysis patients using a Cobe Centrysystem 3 Blood Tubing Set or Cobe Hemodialysis Kit should be reported through state health departments to CDC's Hospital Infections Program, National Center for Infectious Diseases, telephone (404) 639-6413, and to the Food and Drug Administration's MedWatch program, telephone (800) 332-1088.
Multistate Outbreak of Hemolysis in Hemodialysis Patients—Nebraska and Maryland, 1998. JAMA. 1998;280(15):1299-1300. doi:10.1001/jama.280.15.1299