TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION) - CODE 4112 - ANALYSIS OF INFORMATION PROVIDED BY USER/THIRD PARTY CHOSEN SINCE THE CORRECT CODE "ANALYSIS OF IMAGES" IS NOT AVAILABLE. UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). 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. BASED ON THE REVIEW OF THE MANUFACTURING PROCESS, THE TUBING INVOLVED IS SUBJECTED TO A STANDARD, VALIDATED CUTTING OPERATION, WHICH DOES NOT INTRODUCE KNOWN MECHANISMS FOR FOREIGN PARTICLE GENERATION. THE PRODUCT WAS NOT RETURNED, AND THE PARTICULATE WAS NOT ABLE TO BE EVALUATED, THEREFORE ITS COMPOSITION REMAINS UNKNOWN. THEREFORE, THE ROOT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED WITHIN APMS PROCESS SCOPE. IT WAS VERIFIED THAT THERE ARE MANUFACTURING CONTROLS TO RELATED TO THE RELATED MALFUNCTION.

Additional Manufacturer Narrative

IT WAS FURTHER INFORMED THAT THE DEVICE WAS NOT AVAILABLE FOR EVALUATION SINCE IT WAS DISCARDED AT HOSPITAL. NEVERTHELESS, IMAGERY WAS PROVIDED FOR INVESTIGATION. BASED ON THE IMAGE REVIEW, THE REPORT OF "BLACK FLOCCULENT MATERIAL OBSERVED INSIDE OF ONE TUBING" WAS CONFIRMED. THE IMAGE SHOWED A CLOSE-UP OF A PRESSURE TUBING ON TOP OF A TYVEK POUCH FROM THE REPORTED MODEL AND LOT. WHAT APPEARED TO BE A FLOCCULENT BLACK MATERIAL COULD BE OBSERVED INSIDE THE FLUID PATH. NO OTHER VISIBLE INCONSISTENCIES WERE NOTICED. AN ENGINEERING INVESTIGATION WILL BE PERFORMED IN ORDER TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY UPON INVESTIGATION COMPLETION. 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 FLUSHING OF THIS PRESSURE MONITORING SET PRIOR TO PATIENT CONNECTION, A BLACK FLOCCULENT MATERIAL WAS OBSERVED INSIDE OF ONE TUBING. THERE WAS NO PATIENT INVOLVEMENT, SINCE THE ISSUE WAS DETECTED DURING THE PREPARATION STAGE IN THE PREPARATION ROOM. THE DEVICE WAS NOT AVAILABLE FOR EVALUATION, AS IT WAS DISCARDED.