inforMED
MalfunctionFII

*

Received Dec 13, 2009 · Event occurred Nov 12, 2009

Report 1562043 · MDR key 1562043

Device

Generic name

Hemodialysis Machine, Continuous Renal Replacement Therapy

Model number

PRISMAFLEX

Catalog number

*

Lot number

*

Product problems

  • Device Inoperable
  • Device Displays Incorrect Message

Patient

27 YR

  • Blood Loss

Narrative

Description of Event or Problem

SCREEN FROZE, AND THERE WAS A MEMORY ERROR 6. THE BLOOD COULD NOT BE GIVEN BACK TO THE PATIENT.