TERUMO CDI 101 MONITOR
Received May 22, 2012 · Event occurred Jan 28, 2009
Report 1828100-2012-00581 · MDR key 2624284
Device
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING USE OF THE DEVICE FOR A CARDIOPULMONARY BYPASS PROCEDURE, THE UNIT WAS NOT GIVING ACCURATE READINGS. THE SURGICAL PROCEDURE WAS COMPLETED SUCCESSFULLY, AND THERE WAS NO BLOOD LOSS AND NO ADVERSE CONSEQUENCES TO THE PT.
Additional Manufacturer Narrative
DATE OF THE EVENT - THE DATE OF THE EVENT WAS NOT PROVIDED. DATE ENTERED IS ESTIMATED. THIS COMPLAINT COULD NOT BE CONFIRMED. THE INTERFACE MODULE (IM) AND HEMATOCRIT/OXYGEN SATURATION (HSAT) PROBES USED WITH THE CUSTOMER'S SYSTEM WERE NOT AVAILABLE FOR TESTING; THEREFORE, A SERVICE TEST MODULE AND PROBE WERE USED. A COMPARISON BETWEEN THE MONITOR PRINTOUT AND THE BLOOD GAS ANALYSIS (BGA) PRINTOUTS FOR 24 POINTS WAS PERFORMED. READINGS WERE WITHIN 2% HEMATOCRIT FOR ALL POINTS. THIS REPORT IS BEING SUBMITTED TO THE FDA AS A RESULT OF A RETROSPECTIVE REVIEW OF PRODUCT COMPLAINTS.