VAC-PAC

Additional Manufacturer Narrative

NATUS QA EVALUATED THE RETURNED VAC-PAC, WHICH HAD BEEN REPAIRED WITH ONE HALF OF A PATCH NEXT TO THE VALVE STEM. THE RETURNED VAC-PAC WAS SUCTIONED AND REMAINED FIRM FOR 72 HOURS. WHEN THE PATCH WAS REMOVED, THE VAC-PAC SOFTENED. A 0.5CM TEAR WAS OBSERVED 2.0CM FROM THE VALVE STEM, AND QA SUSPECTED THAT THE TEAR MAY HAVE BEEN CAUSED BY A TOWEL CLAMP. THE COMPLAINANT OPTED TO REPLACE THEIR VAC-PAC UNDER WARRANTY. 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.

Description of Event or Problem

NATUS RECEIVED A REPORT THAT A VAC-PAC HAD SOFTENED DURING A LATERAL SHOULDER PROCEDURE WHICH LASTED APPROXIMATELY THREE HOURS. THE COMPLAINANT INITIALLY NOTICED THAT THE VAC-PAC HAD SOFTENED WHEN THE PATIENT WAS PLACED ON IT PRIOR TO SURGERY PREP. SUCTION WAS RE-APPLIED, THE VALVE CAP WAS CLOSED, AND THE VAC-PAC WAS SUBSEQUENTLY USED DURING SURGERY. AFTER THE SURGERY, IT WAS NOTED THAT THE VAC-PAC HAD BECOME FLACCID. UPON INSPECTION OF THE VAC-PAC, A SMALL TEAR WAS NOTICED NEAR THE VALVE AND BEADS ORIGINATING FROM THE VAC-PAC WERE SEEN ON THE PATIENT BED. THE COMPLAINANT STATED THAT VAC-PACS ARE STORED FIRM AND FLAT, AND THEY HAD NOT NOTICED A TEAR PRIOR TO SURGERY. THE VAC-PAC WAS PURCHASED IN (B)(6) 2017. THE COMPLAINANT NOTED A SLIPPING OF AN ARTHREX S3 TRACTION TOWER DURING SURGERY WHICH COULD HAVE POSSIBLY BEEN RELATED TO A LACK OF LATERAL SUPPORT PROVIDED BY THE VAC-PAC. THE COMPLAINANT STATED THAT THE PATIENT DID NOT LOSE POSITION DURING SURGERY AS THE VAC-PAC WAS TAPED TO THE OPERATING ROOM TABLE AND SECURING POSTS WERE ATTACHED. THERE WAS NO REPORT OF DEATH, SERIOUS INJURY, DELAY IN TREATMENT, OR ENVIRONMENTAL/SAFETY CONCERNS. THE COMPLAINANT STATED THAT THERE WAS NO HARM CAUSED TO THE PATIENT.