CAPIOX THERMISTOR WIRE
Received Mar 28, 2011
Report 9681834-2010-00043 · MDR key 2274817
Device
Generic name
Clinical Electronic Thermometer
Manufacturer
Terumo Corp. AshitakaModel number
1CX-BP022Catalog number
NA
Lot number
2010B2
Product problems
- Temperature Problem
Patient
UNK
- No Patient Involvement
Narrative
Description of Event or Problem
THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING SET-UP, THE THERMISTOR WIRE WAS NOT REGISTERING THE TEMP. THIS PROBLEM OCCURRED THREE TIMES, AND COMPLAINTS WERE FILED FOR TWO OF THE EVENTS. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS NO PT INVOLVEMENT.
Additional Manufacturer Narrative
TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVAL AND WILL BE SUBMITTING A FOLLOW-UP WHEN MORE INFO BECOMES AVAILABLE. (B)(4).