US Centers for Disease Control
Multistate outbreak of hemolysis in hemodialysis patients -
Nebraska and Maryland, 1998
Morb Mortal Weekly Rep
(Jun) 47:No.23 1998
Reproduced from the .pdf version of the MMWR June 19, 1998, which is
Multistate Outbreak of Hemolysis in Hemodialysis Patients -
Nebraska and Maryland, 1998
From May 13 through May 23, 1998, a total of 30 patients in three states*
hemolysis with or without chest pains, shortness of breath, nausea, or
while undergoing hemodialysis (HD). Two patients died. This report summarizes
preliminary findings of investigations in Nebraska and Maryland and
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
systolic blood pressure) and evidence of hemolysis (i.e., positive “pink
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,
had illnesses that met the case definition. In addition, case-patients
pain (five), shortness of breath (four), nausea (four), abdominal pain
(three), back pain (two), cyanosis (two), or diarrhea (one). Onset of
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
men. They had received hemodialysis for a median of 3 years (range: <1 to
11 (85%) used reprocessed dialyzers. Of the 13 patients, 11 (85%) required
four (31%), admission to an intensive-care unit (ICU); and three (23%),
transfusion. The 13 case-patients were dialyzed on 12 different machines but
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
lot numbers of blood tubing are not routinely recorded. However, for six case
the blood tubing lot number was 04D15309.
Examination of the implicated blood tubing revealed narrowing of the
through which blood was pumped during the dialysis treatment. Analyses of
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
for the Advancement of Medical Instrumentation.
During May 18-23, a total of 12 (4%) of 298 patients at four HD centers in
developed abdominal pain (eight), nausea (seven), and/or erythroderma (four);
evidence of hemolysis on admission to the hospital. Onset of symptoms
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
men. Case-patients had received hemodialysis for a median of 3 years (range:
>5 years); none used reprocessed dialyzers. All case-patients required
four, admission to ICU; and six, blood transfusion. The 12 case-patients were
on 12 different machines, but all may have been dialyzed using a Cobe
3 Blood Tubing Set (lot number 04D15309) that was present at the clinic
*No data were available for five patients in Massachusetts.
**Use of trade names and commercial sources is for identification only and
does not imply
endorsement by CDC or the U.S. Department of Health and Human Services.
Vol. 47 / No. 23 MMWR 483
On May 25, the manufacturer issued a voluntary nationwide recall of specific
catalog number 003210-500 (including lot number 04D15309) of Cobe
Blood Tubing sets. On June 10, following additional reports (including two
deaths) in Alabama and New Jersey, the manufacturer expanded the recall to
of Cobe Centrysystem 3 Blood Tubing sets and Cobe Hemodialysis kits
blood tubing sets for dialysis with catalog numbers 003109-400, 003109-410,
500, 003111-500, 003112-500, 003113-500, 003114-500, 003210-500, 003212-500,
003101-000, and 003212-515.
Reported by: 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
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
gist, Maryland Dept of Health and Mental Hygiene. Center for Devices and
and Office of Regulatory Affairs, Food and Drug Administration. Div of
Chronic Disease Control
and Prevention, National Center for Chronic Disease Prevention and Health
tional Emergency and Refugee Health Program, National Center for
Hospital Infections Program, National Center for Infectious Diseases; and EIS
In the United States, approximately 225,000 persons with end stage
renal disease undergo long-term hemodialysis each year (1). Hemolysis (i.e.,
breakdown of red blood cells [RBCs]) associated with hemodialysis is rare
(2,3) . The most frequent causes of hemodialysis-associated hemolysis are
chloramine in the water used for dialysis; nitrate contamination of the
residue left after dialyzer reprocessing or water treatment system
use of hypotonic dialysate or dialysate exceeding 108 degrees F (42 degrees
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
produced by a single manufacturer. Preliminary findings suggest that the
aperture of the blood tubing sets caused mechanical lysis of the RBCs.
To ascertain the extent of this problem, all episodes of hemolysis in
using a Cobe Centrysystem 3 Blood Tubing Set or Cobe Hemodialysis Kit should
be reported through state health departments to CDC's Hospital Infections
National Center for Infectious Diseases, telephone (404) 639-6413, and to the
Drug Administration's MedWatch program, telephone (800) 332-1088.
1. Health Care Financing Administration. ESRD facility survey data, 1995.
Washington, DC: US
Department of Health and Human Services, 1995.
2. Sweet SJ, McCarthy S, Steingart R, Callahan T. Hemolytic reactions
mechanically induced by
linked hemodialysis lines. Am J Kidney Dis 1996;27:262-6.
3. Corea AL, Ohanian N, Anderson M, Holloway M. Hemodialysis procedure. In:
Fine RN, Gentile DE, eds. Clinical dialysis. Norwalk, Connecticut, and San
Appleton and Lange, 1990:147-160.
4. Fried W. Hematologic aspects of uremia. In: Nissenson AR, Fine RN, Gentile
DE, eds. Clinical
dialysis. Norwalk, Connecticut, and San Mateo, California: Appleton and