Poorly made plastic tubing in dialysis machines apparently killed two people and hospitalized 35 in at least three states in late May, according to health officials and the manufacturer of the tubing, Gambro Healthcare Inc.
Gambro has recalled 6,000 sets of the PVC tubing and injection molded cartridges that link the tubes to dialysis machines, and believes the problem is limited to one lot manufactured at its Tijuana, Mexico, plant, said Tim Schoenberg, vice president of investor relations for the Lakewood, Colo.-based company.
The tubing was blocked partially by flashing, or excess plastic in the tube, that forced the blood into smaller openings under high pressure. That causes hemolysis, which damages the blood cells and causes abdominal pain, cyanosis and chest pain, company officials said.
``We believe it was isolated to a single run,'' Schoenberg said. ``We are still investigating exactly what occurred.''
Schoenberg said the company has been manufacturing at its own Tijuana facility since 1985.
The two deaths occurred at Bon Secours Baltimore Health Systems in Baltimore. Gambro said other illnesses occurred in Nebraska and Massachusetts. Schoenberg declined to say what other illnesses occurred in those states. Schoenberg declined to say what other states received the product, but said the Cobe Centrysystem 3 tubes were recalled from 31 clinics and four distributors.
Gambro officials said they told the Food and Drug Administration immediately after discovering the problem May 22, and initiated a voluntary recall May 25. The company said it has been working closely with federal and state health officials.
FDA spokesman Brad Stone said the agency is monitoring the recall and still is investigating, but agreed with Gambro's assessment that the problem seemed to be from blockage of the tubing.
Gambro makes dialysis equipment and operates renal-care clinics in North America. It is part of Stockholm, Sweden-based Incentive, which had about $2.5 billion in sales last year.