TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

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, PRIOR TO CONNECTING THIS PRESSURE MONITORING SET TO THE PATIENT, THE PRESSURE TUBING BECAME DETACHED. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS BEEN RECEIVED YET.

Additional Manufacturer Narrative

UPDATED SECTIONS D9 (DEVICE AVAILABILITY), G1 (CONTACT OFFICE EMAIL ADDRESS AND TELEPHONE NUMBER), H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). THE DEVICE WAS RECEIVED FOR EVALUATION. THE REPORT OF PRESSURE TUBING DETACHED WAS NOT ABLE TO BE CONFIRMED, SINCE NO DEFECT WAS FOUND ON THE RETURNED DEVICE. AS RECEIVED, ALL CONNECTIONS WERE TIGHT AND SECURE. 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. FINALLY, NO VISIBLE DAMAGE, OR DEFECT WAS OBSERVED FROM THE KIT DURING VISUAL EXAMINATION. FURTHER INVESTIGATION WAS PERFORMED BY THE ENGINEERS. BASED ON THE AVAILABLE INFORMATION THE INVESTIGATION DID NOT FIND ANY DEVICE DEFECT RELATED TO THE ISSUE, SINCE NO DEFECT WAS FOUND ON THE RETURNED DEVICE. AS PART OF THE MANUFACTURING PROCESS, THE UNITS GO THROUGH A SAMPLING AND VISUAL INSPECTION TO VERIFY THE INTEGRITY OF THE DEVICE. ALL EVENTS WILL CONTINUE TO BE REVIEWED AND MONITORED.