SAPPH NV 1.2FLTR CLAVE-Y 289CM

Additional Manufacturer Narrative

SEVEN NEW SAPPHIRE PRIMARY 1.2 MICRON FILTER SET, NON-VENTED, CLAVE Y-SITE, 289 CM WERE RECEIVED. EACH SET WAS VISUALLY INSPECTED AND NO ANOMALIES WERE FOUND AS RECEIVED. EACH SET WAS AIR PRESSURE LEAK TESTED PER PRODUCT SPECIFICATIONS AND NO LEAKS WERE FOUND ANYWHERE. EACH SET WAS INSTALLED IN AN ICU MEDICAL PROVIDED SAPPHIRE PUMP AND A TEST INFUSION WAS PERFORMED. NO AIR BUBBLES OR PROBLEMS WERE FOUND AND EACH TEST COMPLETED SUCCESSFULLY. AIR WAS INTENTIONALLY INTRODUCED INTO ONE SET AND ALLOWED TO TRAVEL THROUGH THE LINE, THE AIR FILTER FUNCTIONED AS INTENTIONED AND ALLOWED AIR TO ESCAPE BEFORE IT WAS DELIVERED TO THE PROXIMAL END OF THE SET. THE COMPLAINT CANNOT BE CONFIRMED ON THE NEW SETS AND THE ORIGINAL SET WAS NOT RETURNED FOR EVALUATION. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. D9 - DATE RETURNED TO MFG: 08-APR-2021.

Additional Manufacturer Narrative

AN UNUSED DEVICE FROM THE SAME LOT NUMBER IS AVAILABLE FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

Description of Event or Problem

THE EVENT OCCURRED IN A HOME CARE SETTING AND INVOLVED A SAPPH NV 1.2FLTR CLAVE-Y 289CM THAT DESPITE THOROUGH PRIMING OF THE TUBING, SIGNIFICANT AIR BUBBLES APPEARED AT THE LEVEL OF THE FILTER WHICH NEVERTHELESS SEEMED PRIMED AS SOON AS THE TUBING MOVED. THIS OCCURRED DURING INFUSION AND THERE WAS A NEED FOR MONITORING THROUGHOUT; HOWEVER, THERE WERE NO NEGATIVE PATIENT CONSEQUENCES. THERE WAS NO ALARM BECAUSE THE AIR APPEARED DOWNSTREAM OF THE PUMP. THE MOTHER OF THE PATIENT HAD TO INTERVENE SEVERAL TIMES TO AVOID AN INJECTION OF AIR AT THE LEVEL OF THE CENTRAL VENOUS LINE. THE FAMILY REQUESTED A PUMP REPLACEMENT. AN ADVISOR NURSE HAD TO GO TO THE PATIENT'S HOME FOR VERIFICATION AND RECOMMENDED TO CHECK THE TUBING THROUGHOUT THE INFUSION AND TO REVERT THE FILTER DURING PRIMING SO THAT FEWER BUBBLES WOULD BE ALLOWED. NO PHYSICAL DEFECTS WERE NOTED ON THE MEDICAL DEVICE, SUCH AS HOLES, CUTS, OR TEARS. THE PUMP WAS REPLACED WITH ANOTHER MODEL ON (B)(6) 2020. THERE WAS NO DELAY IN THERAPY AND NO BLOOD LOSS. THERE WAS PATIENT INVOLVEMENT; HOWEVER, THERE WERE NO ADVERSE EVENTS, NO NEED FOR MEDICAL INTERVENTION, AND NO HUMAN HARM.