MalfunctionCBZ
TERUMO KHURI MYOCARDIAL PH MONITOR
Received Jan 26, 2006 · Event occurred Dec 14, 2005
Report 2023117-2006-00001 · MDR key 669555
Device
Generic name
Indwelling Ph Sensor
Manufacturer
Terumo Cardiovascular Systems Corp.Model number
7205Catalog number
7205
Lot number
2006-03AF
Product problems
- Incorrect Or Inadequate Test Results
Patient
*
Narrative
Description of Event or Problem
DURING USE OF THE MYOCARDIAL PH SENSOR DURING CARDIOPULMONARY BYPASS SURGERY, THE SENSOR EXHIBITED INACCURATE PH VALUES TO AN EXTENT THAT COULD HAVE CAUSED THE SURGEON TO DRAW INCORRECT CONCLUSIONS ABOUT THE STATUS OF THE HEART TISSUE PH. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT AS A RESULT OF THIS EVENT.