TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

ADDED INFORMATION TO SECTION H6 (TYPE OF INVESTIGATION). UPDATED SECTION H6 (COMPONENT CODE), H6 (INVESTIGATION FINDINGS) AND H6 (INVESTIGATIONS CONCLUSIONS). THE REPORTED MALFUNCTION COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED SINCE NO PRODUCT SAMPLES OR IMAGES WERE PROVIDED; HOWEVER, THERE ARE MANUFACTURING CONTROLS RELATED TO THE REPORTED MALFUNCTION. 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.

Additional Manufacturer Narrative

THE PRODUCT IS NOT EXPECTED TO BE RETURNED FOR ANALYSIS SINCE IT WAS DISCARDED. AN INVESTIGATION WILL BE COMPLETED TO CONSIDER ANY POTENTIAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS COMPLAINT AND 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.

Description of Event or Problem

AS REPORTED, WHEN RETURNING BLOOD FROM PREVIOUSLY EXTRACTED BLOOD SAMPLE TO AN ICU PATIENT, THIS DISPOSABLE PRESSURE TRANSDUCER (DPT) WITH VAMP JUNIOR EXPERIENCED RESISTANCE, AS CONSEQUENCE, BLOOD SPRAYED FROM SAMPLE PORT TO STAFF MEMBER FACE AND TRUNK. THE DISTAL STOPCOCK WAS OPEN DURING PROCESS. A NEW TRANSDUCER WAS USED FROM THE SAME LOT, HOWEVER, IT ALSO EXPERIENCED RESISTANCE PUSHING THE PLUNGER RESULTING IN SALINE SPRAYING FROM SAMPLE PORT. THE NURSE WORE GLOVES BUT NO GOGGLES NOR FACEMASK. SEROLOGY TESTS WERE PERFORMED TO THE PATIENT AND NURSE AND CAME BACK NEGATIVE. THERE WAS NO ALLEGATION OF PATIENT INJURY.