TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

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. ALL PROCESS PARAMETERS WERE MET AND INSPECTIONS PASSED SUCCESSFULLY. THERE ARE MANUFACTURING CONTROLS TO RELATED TO THE "DURING USE INCORRECT FLOW RATE" MALFUNCTION.

Additional Manufacturer Narrative

A4. WEIGHT 740 GRAMS. THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT BEEN RECEIVED YET. UPON THE RETURN OF THE PRODUCT, 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.

Description of Event or Problem

AS REPORTED, DURING USE IN A NEONATAL PATIENT, THIS PRESSURE MONITORING KIT ADMINISTRATED TOO MUCH FLUID BECAUSE OF HIGHER FLOW RATE: FROM 0.2 TO 0.3 CC/HOUR. THE VOLUME OF SALINE ADMINISTRATED OVER 48 HOURS WAS ABOUT 120ML. ALL THE CONNECTIONS WERE CORRECTLY MADE. THEN, IT WAS DECIDED TO REMOVE THE UMBILICAL CATHETER. THE PATIENT HAD AN ELECTROLYTE IMBALANCE, GAINED TOO MUCH WEIGHT, AND SUFFERED A RESPIRATORY DEGRADATION. UNKNOWN MEDICATION WAS PROVIDED FOR IONIC REBALANCING. THE DEVICE WAS AVAILABLE FOR EVALUATION.