VAC-PAC

Additional Manufacturer Narrative

THE TSR EMAILED THE CUSTOMER TO REQUEST MORE INFORMATION AND THE RETURN OF THE SUSPECT VAC-PAC DEVICE. ON 5/08/2018, THE TSR E-MAILED THE CUSTOMER AGAIN, ASKING THE CUSTOMER IF THE VAC-PAC AND QUESTIONNAIRE HAD BEEN RETURNED TO NATUS MEDICAL. ON 5/18/2018, THE TSR SENT ANOTHER FOLLOW-UP E-MAIL WITH NO RESPONSE. 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 REPORTED TO A NATUS MEDICAL TECHNICAL SERVICE REPRESENTATIVE (TSR) THAT SIZE 32 VAC-PAC, LOT #56 AND PURCHASED IN NOVEMBER 2014, DID NOT FULLY SUCTION FIRM DURING SURGERY. THERE HAS BEEN NO REPORT OF DEATH, SERIOUS INJURY OR ENVIRONMENTAL/SAFETY CONCERNS. THE VAC-PAC HAS BEEN REPORTED TO HAVE BEEN USED DURING A TWO HOUR DEBRIDEMENT OF A THORACIC SPINE WOUND. THE PATIENT HAS BEEN REPORTED TO HAVE BEEN IN THE LATERAL POSITION, AND THE PATIENT (B)(6). THE CUSTOMER STATED THE VAC-PAC WAS ON CONTINUOUS SUCTION THROUGHOUT THE CASE, BUT THAT THEY NOTICED ALMOST IMMEDIATELY AFTER THE PROCEDURE BEGAN THAT THE VAC-PAC WAS NOT AS FIRM AS IT SHOULD BE. THE CUSTOMER ALSO REPORTED THAT THE PATIENT'S ABDOMINAL PANNICULUS WAS PUSHING UP AGAINST THE SIDE OF THE VAC-PAC AND THAT THE SCRUB TECHNICIAN WAS ABLE TO KEEP THE PATIENT FROM MOVING OR SHIFTING. THE CUSTOMER COULD NOT CONFIRM WHETHER STRAPS WERE IN USE DURING SURGERY BUT STATED THE VAC-PAC AND PATIENT HAD BEEN TAPED TO THE OPERATING ROOM TABLE. THE TAPE HAD NOT BEEN APPLIED AROUND THE ENTIRE TABLE, AND BECAUSE OF THIS THE TAPE DID NOT HOLD VERY WELL. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATION AND THERE WAS NO HARM TO THE PATIENT.