inforMED
InjuryFII

GAMBRO REVACLEAR DIALYZER K6

Received Dec 13, 2013 · Event occurred Dec 11, 2013

Report MW5033463 · MDR key 3525089

Device

Generic name

Dialysis Machine K6

Manufacturer

Gambro

Lot number

C413124601

Product problems

  • Fluid/Blood Leak

Patient

42 YR

  • No Information

Narrative

Description of Event or Problem

PT WAS PLACED ON THE GAMBRO REVACLEAR DIALYZER MACHINE K6 AND IT WAS NOTICED THAT THERE WAS BLOOD LEAKING IN THE DIALYZER. THE TREATMENT WAS TERMINATED PRIOR TO THE BLOOD FULLY CIRCULATING THROUGH THE SYSTEM. THE PATIENT WAS MADE SAFE AND THE NEPHROLOGIST WAS NOTIFIED.