ABVISER AUTOVALVE VALVE IAP MONITORING DEVICE WITH ICU MEDICAL TRANSPAC TRANSDUC

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION, THIS EVENT IS DEEMED A REPORTABLE MALFUNCTION. THERE WERE NO REPORTS OF THE PATIENT BEING HARMED AS A RESULT OF THIS MALFUNCTION. ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN REQUESTED. HOWEVER, NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THE REPORT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AFTER ONE DAY IN USE, THE RN NOTED THAT URINE WAS NOT FLOWING IN THE DEVICE. THE DEVICE WAS REMOVED AND IT WAS DISCOVERED THAT THE GREEN OCCLUSION DEVICE REMAINED INFLATED. THERE WAS NO ISSUE WITH URETHRAL CATHETER. THE RN FURTHER REPORTED THAT THE PATIENT HAD 800 MILLILITERS OF URINE OUTPUT AFTER REMOVAL OF THE DEVICE. A NEW DEVICE WAS PLACED AND THERE WERE NO FURTHER ISSUES REPORTED. THE PATIENT WAS SEDATED AND VENTILATED AND DID NOT EXHIBIT ANY COMPLAINTS.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) , 2015. THIRD PARTY MANUFACTURER CONFIRMED NO LOT NUMBER WAS AVAILABLE FOR THE RETURNED UNIT FOR TRACEABILITY. THEREFORE A SIX MONTH HISTORICAL BATCH RECORD REVIEW WAS PERFORMED FOR LOT# ABV331 FROM (B)(6) 2015. ALL SAMPLES POST STERILIZATION WERE SUBJECTED TO THE AIR TEST FOR THE AUTO VALVE FUNCTION WHICH MET THE SPECIFICATION FOR OPERATIONAL TIMING. THE ABVISOR REQUIRES A 100% AIR TEST DURING THE MANUFACTURING PROCESS TO ENSURE THE AUTO VALVE FUNCTIONS PROPERLY. THE SAMPLE WAS VISUALLY EXAMINED UNDER THE MICROSCOPE AND THE IT WAS DISCOVERED THAT THE TIMING HOLE WAS CLOGGED WITH A SOFT MATERIAL PARTICLE, YELLOW AND BROWN IN COLOR. IT WAS TOO SMALL TO DETERMINE THE EXACT SOURCE. AFTER THOROUGHLY INVESTIGATING THE PARTICLE IT COULD BE GREASE OR OIL THAT ACCUMULATED OVER TIME DURING THE PATIENTS USE AND LED TO THE CLOG IN THE TIMING HOLE. NO PREVIOUS INVESTIGATIONS ARE AVAILABLE. AFTER A REVIEW OF THE RETURNED PRODUCT AND A THOROUGH BATCH REVIEW NO DISCREPANCIES, NON-CONFORMANCES OR DEVIATIONS WERE FOUND. THERE IS NOT ENOUGH INFORMATION TO CONCLUDE THE PRODUCT DID NOT MEET SPECIFICATION AND PERFORM AS INTENDED. PRODUCT MONITORING REVIEWS WILL MONITOR FOR PRODUCT TRENDS IF THIS ISSUE WERE TO REOCCUR. NO FURTHER ACTIONS ARE REQUIRED AND THE COMPLAINT WILL BE CLOSED. NO ADDITIONAL PATIENT/EVENT DETAILS HAVE BEEN PROVIDED TO DATE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE A FOLLOW-UP REPORT WILL BE SUBMITTED.