inforMED
MalfunctionFII

CRRT

Received May 22, 2010 · Event occurred Feb 16, 2010

Report 1730633 · MDR key 1730633

Device

Generic name

Crrt

Manufacturer

Gambro

Model number

PRISMAFLEX

Catalog number

NA

Lot number

NA

Product problems

  • Device Alarm System
  • Device Displays Incorrect Message
  • Device Contamination with Chemical or Other Material

Patient

*

  • No Information

Narrative

Description of Event or Problem

CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS IN RECIRC MODE. THE MACHINE ALARMED AIR IN LINE. THERE WAS NO AIR PRESENT BUT THERE WAS OBVIOUS SEDIMENT PRESENT. A HAND CRANK WAS USED TO MOVE THE SEDIMENT PAST THE AIR LEAK DETECTOR AND THEN THE MACHINE WENT INTO "GENERAL SYSTEM FAILURE." THE CIRCUIT WAS TAKEN DOWN, DATA WAS DOWNLOADED AND A NEW CIRCUIT WAS PLACED.