TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

UPDATED SECTION D9, H6 (COMPONENT CODE), H6 (TYPE OF INVESTIGATION), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THE DEVICE WAS RECEIVED FOR EVALUATION. THE REPORT OF DETACHED TUBING WAS UNABLE TO BE CONFIRMED. AS RECEIVED, ALL CONNECTIONS WERE TIGHT AND SECURE. NO VISIBLE DAMAGE/DEFECT WAS OBSERVED FROM THE KIT DURING VISUAL EXAMINATION. NO LEAKAGE WAS OBSERVED FROM THE KIT DURING LEAK TEST. NO LUER CONNECTIONS GOT LOOSE OR DETACHED DURING EVALUATION. ALL MALE AND FEMALE LUERS AND TUBING CONNECTORS DIMENSIONALLY PASSED ISO STANDARDS. NO VISIBLE DAMAGE/DEFECT WAS OBSERVED FROM THE KIT. NO DEFICIENCIES WERE IDENTIFIED ON THE RETURNED PRODUCT. IT WAS VERIFIED THAT THERE ARE INTERNAL CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION.

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 A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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, BEFORE USE IN A PATIENT WITH THIS PRESSURE MONITORING SET, THE PRESSURE TUBING BECAME DETACHED. REPLACING THE DEVICE WITH A NEW ONE SOLVED THE ISSUE. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.