TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, DURING USE IN AN INTENSIVE CARE PATIENT WITH DISSEMINATED INTRAVASCULAR COAGULATION (DIC), THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) CONNECTED TO THE RADIAL CATHETER, DISPLAYED AN ABNORMALLY LOW BLOOD PRESSURE VALUE. THERE WAS NO ERROR MESSAGE DISPLAYED. CONSEQUENTLY, THE PATIENT WAS TREATED WITH A HIGH DOSE OF VASOPRESSORS AS FLUID RESUSCITATION. SINCE THE VALUES DID NOT CHANGE 3 HOURS AFTER ADMINISTERING THE MEDICATION, ANOTHER PRESSURE SENSOR WAS CONNECTED TO THE FEMORAL VEIN, WHICH SHOWED PRESSURE VALUES CONSIDERED TO BE CORRECT OF 197MMHG/68MMHG. THE DPT SHOWED PRESSURE VALUES OF 131MMHG/59MM HG. ALSO, A CUFF WAS CONNECTED AND SHOWED PRESSURE VALUES WHICH WERE IN BETWEEN THE RADIAL AND THE FEMORAL VALUES AND WERE ALSO CONSIDERED TO BE CORRECT. DECREASING THE AMINES LED TO PATIENT IMPROVEMENT, AND THE VALUES FROM THE FEMORAL SENSOR SEEMED COHERENT WITH PATIENT CONDITION. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT AN INVESTIGATION WILL BE COMPLETED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. 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 PART OF THIS MONTHLY REVIEW.

Additional Manufacturer Narrative

UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). FINALLY, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION DESPITE DUE DILIGENT ATTEMPTS. WITHOUT RETURN OF THE PRODUCT, A COMPLETE INVESTIGATION OF THE REPORTED EVENT IS UNABLE TO BE PERFORMED. IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED. THE MANUFACTURING RECORDS WERE REVIEWED FOR THE LOT INVOLVED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION.