TRUWAVE

Additional Manufacturer Narrative

THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. THE LOT NUMBER WAS NOT PROVIDED THUS A DEVICE HISTORY RECORD WAS NOT REVIEWED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW. G4. ADDITIONAL 510K: K171996, K183413.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE ON PATIENT, THIS PRESSURE MONITORING KIT SUDDENLY DISPLAYED -400 MMHG (EXPECTED RANGE WAS 200 TO 300 MMHG) OF ARTERIAL LINE PRESSURE WHILE THE PATIENT WAS ASSISTED WITH ARTIFICIAL HEART-LUNG MACHINE. NO ISSUE WAS OBSERVED DURING ZEROING PRIOR TO USE, AND MEASUREMENTS WERE NORMAL AT THE BEGINNING OF USE. THE ISSUE WAS RESOLVED BY REPLACING THE DEVICE WITH ANOTHER ONE. ACCORDING TO THE CUSTOMER, THE TAPE WHICH THE CUSTOMER APPLIED AROUND THE CONNECTION CONFIRMED TO BE CAUGHT IN THE CONNECTION AREA. THEREFORE, THE CUSTOMER CONSIDERED THIS MAY HAVE CAUSED THE CONNECTION TO LOOSEN OR BE AFFECTED, RESULTING IN THE ABNORMAL READING. AFTER THE OPERATION, THE CUSTOMER APPLIED PRESSURE TO THE DEVICE USING A SYRINGE AND PERFORMED A MEASUREMENT; HOWEVER, THE ABNORMAL VALUE COULD NOT BE REPLICATED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT THE HOSPITAL.