TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, BEFORE USE IN PATIENT, THE PRESSURE TUBING OF THIS DISPOSABLE PRESSURE TRANSDUCER WAS DETACHED AT THE TOP OF THE SENSOR. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION.

Additional Manufacturer Narrative

PATIENT DEMOGRAPHICS UNABLE TO BE OBTAINED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. 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. 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

ADDED: H2 (TYPE OF FOLLOW-UP). UPDATED: D9 (DEVICE AVAILABILITY FOR EVALUATION), 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 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, NO VISIBLE DAMAGE WAS OBSERVED FROM RETURNED KIT. ALL CONNECTIONS WERE TIGHT. HOWEVER, YELLOW STAND-ALONE STOPCOCK AND ATTACHED PRESSURE TUBING WERE MISSING FROM RETURNED KIT. KIT SHOULD INCLUDE TWO STAND-ALONE STOPCOCKS WITH ATTACHED PRESSURE TUBING, ONE WITH EACH DPT LINE. BASED ON FURTHER INVESTIGATION PERFORMED BY ENGINEERS, A DEFINITE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. BASED ON THE AVAILABLE INFORMATION, NO ACTION WAS REQUIRED AT THIS TIME; HOWEVER, 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.