TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

ADDED: H2 (TYPE OF FOLLOW-UP). UPDATED: G3 (DATE RECEIVED BY MANUFACTURER), G6 (TYPE OF REPORT), H3 (DEVICE EVALUATED BY MANUFACTURER), H6 (COMPONENT CODE, TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS). THE DEVICE INVOLVED IN THIS CASE WAS RECEIVED BY OUR PRODUCT EVALUATION LABORATORY. 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. EVALUATION RESULTS REVEALED THAT THE REPORTED EVENT COULD NOT BE CONFIRMED, SINCE NO DEFECT WAS FOUND ON THE RETURNED DEVICE. BASED ON THE AVAILABLE INFORMATION, A DEFINITE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. 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.

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 NOT BEEN RECEIVED YET.