TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

THE DEVICE INVOLVED IN THIS COMPLAINT WAS RECEIVED BY OUR PRODUCT EVALUATION LABORATORY FOR A FULL EXAMINATION. THE REPORT OF PART LOOSE WAS CONFIRMED. AS RECEIVED, ALL CONNECTIONS WERE TIGHT AND SECURE. NO LEAKAGE WAS DETECTED FROM THE KIT DURING LEAK TEST. HOWEVER, FILTER WAS FOUND DISLODGED INSIDE DRIP CHAMBER DURING VISUAL EXAMINATION. NO OTHER VISIBLE DAMAGE OR INCONSISTENCY WAS OBSERVED FROM THE KIT. FURTHER ENGINEERING INVESTIGATION IS BEING PERFORMED, WHEN THE PRODUCT INVESTIGATION IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS.

Description of Event or Problem

AS REPORTED, WHEN SETTING UP THIS DISPOSABLE TRANSDUCER, A PART WAS LOOSE. NO FURTHER INFORMATION AVAILABLE. THERE IS NO ALLEGATION OF PATIENT INJURY. AS PER PRODUCT EVALUATION FINDINGS, FILTER WAS FOUND DISLODGED INSIDE DRIP CHAMBER DURING VISUAL EXAMINATION. PATIENT DEMOGRAPHICS WERE NOT PROVIDED.

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION). UPDATED SECTION 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. IT WAS DETERMINED THAT THIS ISSUE IS RELATED TO THE SUPPLIER PROCESS; THEREFORE, THE SUPPLIER HAS BEEN NOTIFIED IN ORDER TO PERFORM AN INVESTIGATION TO AVOID THE RECURRENCE OF THIS ISSUE. ADDITIONALLY, THERE ARE MANUFACTURING CONTROLS FOR THE REPORTED MALFUNCTION.