MalfunctionDTY
TERUMO CDI 101 MONITOR
Received Aug 9, 2011 · Event occurred Feb 2, 2011
Report 1828100-2011-02576 · MDR key 2219879
Device
Product problems
- Connection Problem
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
EVALUATION IN PROGRESS, BUT NOT YET CONCLUDED.
Description of Event or Problem
DURING PRIMING OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE USER REPORTED THAT THE CONNECTION BETWEEN THE INTERFACE CABLE AND THE INTERFACE MODULE WAS VERY TIGHT. THE DEVICE WAS NOT CHANGED OUT. THE USER REPORTED THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.