inforMED
MalfunctionDTY

TERUMO CDI 101 MONITOR

Received Sep 9, 2011 · Event occurred Aug 18, 2011

Report 1828100-2011-02748 · MDR key 2266784

Device

Generic name

Interface Module

Model number

7101

Catalog number

7101

Product problems

  • Communication or Transmission Problem

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Description of Event or Problem

DURING PREPARATION OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE INTERFACE MODULE DID NOT INTERFACE WITH THE CDI 100. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PT AS A RESULT OF THIS EVENT.