VAC-PAC

Additional Manufacturer Narrative

THE SUSPECT VAC PAC DEVICE WAS RETURNED TO NATUS AND EVALUATED. A VISUAL INSPECTION CONFIRMED A 30MM CLEAN CUT IN THE INTERIOR "U SHAPE EDGE. THE CUT WAS PATCHED WITH 10CM X 10CM CLOTH TAPE. BEADS ARE COMING OUT OF THE CUT, AND THE CUT IS FOUND ON BOTH THE INTERIOR AND EXTERIOR SURFACES OF THE VAC PAC. THE UNIT WAS RETURNED WITH TRANSPARENT DRESSING COVERING UP A POSSIBLE PINHOLE ON BACK OF THE VAC PAC. A VISUAL INSPECTION ALSO CONFIRMED VISIBLE VALVE DAMAGE ON SURFACE OF THE VALVE OPENING WHERE THE VALVE PLUG GOES IN. PRODUCT EXAMINATION ALSO CONFIRMED THAT THE LABEL DOES NOT ADHERE WELL ON SURFACE OF THE VAC PAC. THE LIKELY CAUSE OF THE LOSS OF SUCTION IS CUSTOMER-CAUSED DAMAGE. THE CUSTOMER WAS PROVIDED INFORMATION FOR STORAGE, REPAIR, TESTING AND REPLACEMENT. USERS ARE INSTRUCTED TO CHECK THE VAC PAC DEVICE BEFORE AND AFTER EACH USE AND NOT TO USE THE DEVICE IF THERE IS KNOWN DAMAGE OR A LEAK. USERS ARE ALSO INSTRUCTED TO REPLACE UNITS OLDER THAN TWO YEARS THAT ARE USED SEVERAL TIMES A WEEK.

Description of Event or Problem

THE CUSTOMER CONTACTED NATUS TECHNICAL SERVICE TO REPORT THAT THEIR VAC PAC LOST SUCTION DURING ROBOTIC RIGHT NEPHRO-URETEROPLASTY SURGERY. THE PATIENT WAS IN THE LATERAL "JACK-KNIFE" POSITION. SURGICAL STAFF NOTICED IMMEDIATELY THAT THE PATIENT BEGAN TO SHIFT ON THE OPERATING ROOM TABLE. THE CUSTOMER REPORTED THAT AFTER THE PATIENT FELL INTO THE ARMS OF A SURGICAL ASSISTANT, THEY DISCOVERED A ONE INCH CUT/TEAR (APPROXIMATELY) NEAR THE SEAM OF THE VAC PAC. THE CUSTOMER REPORTED THAT THEY APPLIED TAPE TO THE AFFECTED AREA, AND SURGICAL STAFF THEN REPOSITIONED AND SECURED THE PATIENT BEFORE CONTINUING THE SURGERY. BEADS WERE FOUND ON THE FLOOR AFTER THE SURGICAL DRAPES WERE REMOVED FROM THE PATIENT. THE CUSTOMER REPORTED A DELAY IN SURGERY WHILE THE PATIENT WAS BEING REPOSITIONED AND SECURED, AND THERE HAS BEEN NO REPORT OF PATIENT OR USER HARM. THE VAC PAC HAS BEEN REPORTED TO HAVE BEEN PURCHASED IN AUGUST 2016 AND HAS BEEN RETURNED TO NATUS FOR EVALUATION.