inforMED
MalfunctionFII

MDR event

Received Dec 23, 2008

Report 9616240-2008-00053 · MDR key 1317923

Device

Product problems

  • Disconnection
  • Fluid/Blood Leak

Patient

Not reported

  • Burn(s)
  • Burn, Thermal

Narrative

Additional Manufacturer Narrative

THE GAMBRO TECHNICAL INVESTIGATION DETERMINED THAT AT THE TIME OF THE DISCONNECTION EVENT, THE NURSE WAS STANDING CLOSE TO THE MACHINE, CLEANING THE EXTERNAL SURFACES.