Another death apparently related to defective plastic tubing prompted Gambro Healthcare Inc. on June 10 to expand the recall of its dialysis kits and stop production of that line.
A death June 8 in Birmingham, Ala. — the fourth in a month — indicates the defective PVC tubing was not limited to one particular batch, as previously thought, said spokesman Tim Schoenberg.
The Lakewood, Colo.-based firm issued a limited recall May 25, but expanded it June 10 to include all of the Cobe Centrysystem 3 blood tubing sets, which account for about 10 percent of the firm's production. The tubing reportedly went to 280 clinics.
``We felt very confident that we had isolated the problem,'' Schoenberg said. ``Obviously what we did not capture was the full range — it occurred in another lot.''
The company also did not issue an immediate recall of all of the tubing last month because it needed to be confident it had enough substitute products, Schoenberg said.
Gambro is converting all of the customers using that tubing to a newer design that is made differently, has different quality-control processes and has every piece of tubing inspected, he said.
``The key is 100 percent inspection,'' he said.
The tubing in the affected lots was not 100 percent inspected, but Schoenberg said that is not unusual in the industry.
Four deaths and other injuries apparently were related to tubing blocked by flashing, or excess plastic, that forced blood into smaller openings under high pressure. In such cases, hemolysis can occur, damaging blood cells and causing abdominal pain, cyanosis and chest pain, the company said.
Gambro believes it has identified what caused the tubing to become blocked, but Schoenberg declined to elaborate.
The death in Alabama came after three deaths were reported in May — two in Maryland and one in New Jersey. The New Jersey death was not disclosed until June 10 because the company was not notified immediately, Schoenberg said.
Injuries also were reported in Nebraska and Massachusetts, Gambro said.
All of the recalled tubing had been made at the company's Tijuana, Mexico, facility. Gambro said both recalls were voluntary.