PRESSURE MONITORING SET

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. 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 A PART OF THE MONTHLY REVIEW.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE VAMP, WHEN RETURNING THE BLOOD USING THE VAMP RESERVOIR DURING BLOOD SAMPLING THE PRESSURE MONITORING KIT SPLASHED THE BLOOD FROM THE PATIENT SIDE'S PLANECTA. THE BLOOD SPLASHED ONTO THE NEXT BED AFTER PASSING THROUGH THE MESH SECTION ABOVE THE APPROXIMATELY 2-METER FABRIC CURTAIN. THE BLOODSTAIN WAS FOUND ON THE PILLOW AREA OF THE PATIENT IN THE NEXT BED. IT IS UNKNOWN IF THE BLOOD GOT ON THE FACE OF THE PATIENT IN THE NEXT BED, AS DURING THE MORNING CARE BY THE HEALTHCARE WORKER, BLOOD SPLASH WAS NOT NOTICED ON THE FACE OF THE PATIENT IN THE NEXT BED, HOWEVER, BLOODSTAIN WAS DISCOVERED LATER ON THE PILLOW AREA. SINCE THERE WAS A POSSIBILITY THAT BLOOD GOT ON THE FACE OF THE PATIENT, BOTH OF THE PATIENTS UNDERWENT ANTIBODY TESTS, AND IT WAS CONFIRMED THAT THERE WAS NO INFECTION. ONLY THE PATIENT SIDE'S PLANECTA WITH THE STOPCOCK WAS USED. IT WAS NOTED THAT THE OUTER CANNULA OF THE SURFLO WAS FOUND TO BE BENT AT THE TIME OF PRODUCT RETRIEVAL. THE KIT WAS NOT REPLACED AFTER THE ISSUE OCCURRED, AND THE MEASUREMENT WAS CONTINUED WITH THE SAME KIT. NO ABNORMALITIES WERE OBSERVED IN THE PRESSURE WAVEFORM, AND THE USE OF THE KIT WAS COMPLETED WITHIN THE SAME DAY. THE PATIENT WAS AN ADULT. NO TRANSFUSION NOR EXTENSION OF HOSPITALIZATION WAS REQUIRED. NO INFECTIOUS DISEASE WAS REPORTED, AND THERE WAS NO ALLEGATION OF PATIENT INJURY. THERE WAS NO ALLEGATION OF PATIENT INJURY REGARDING THE PATIENT IN THE NEXT BED.