TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, AFTER ONE HOUR CONNECTED, WHEN DRAWING BLOOD, THIS DISPOSABLE PRESSURE TRANSDUCER WITH VAMP, LEAKED SALINE AND APPROXIMATELY 3-5 INCHES OF AIR ENTERED IN TO THE SYSTEM FROM THE TUBING CONNECTOR TO THE TREE-WAY KEY NEXT TO THE VAMP. THE BLOOD REMAINED IN THE SYSTEM; THERE WAS NO BLOOD LEAKING. THE DEVICE WAS REPLACED WITH A NEW UNIT. THERE WAS NO ALLEGATION OF PATIENT INJURY. PATIENT DEMOGRAPHICS COULD NOT BE PROVIDED.

Additional Manufacturer Narrative

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. PATIENT DEMOGRAPHICS UNABLE TO BE PROVIDED. 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.

Additional Manufacturer Narrative

UPDATED SECTION H6 (INVESTIGATION FINDINGS AND INVESTIGATION CONCLUSIONS). FINALLY, THE DEVICE WAS NOT AVAILABLE FOR EVALUATION DESPITE DUE DILIGENT ATTEMPTS. NEVERTHELESS, ONE IMAGE WAS PROVIDED. BASED ON IMAGE EVALUATION PERFORMED BY THE ENGINEERS, THE IMAGE WAS SHOWING A BLOOD TRACE WITHIN THE TUBING; HOWEVER, NO SALINE LEAKAGE IS VISIBLE. HOWEVER, THERE IS NO EVIDENCE TO CONFIRM A DEVICE MALFUNCTION. NO OBJECTIVE DATA HAS BEEN PROVIDED TO IDENTIFY A DEVICE RELATED ISSUE. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE; ALL PROCESS PARAMETERS WERE MET, AND INSPECTIONS PASSED SUCCESSFULLY. FURTHER INVESTIGATION WAS PERFORMED AT THE MANUFACTURING SITE. WITHOUT RETURN OF THE PRODUCT, A COMPLETE INVESTIGATION OF THE REPORTED EVENT IS UNABLE TO BE PERFORMED. IT IS NOT POSSIBLE TO DETERMINE A ROOT CAUSE OR WHAT FACTORS MAY HAVE CONTRIBUTED TO IT, AND THEREFORE NO ACTIONS COULD BE PLANNED. THERE ARE INTERNAL CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO THE REPORTED MALFUNCTION. ALL EVENTS WILL CONTINUE TO BE REVIEWED AND MONITORED.