SAPPHIRE PRIMARY 1.2 MICRON FILTER SET, NON-VENTED, MICROBORE, 311 CM

Additional Manufacturer Narrative

THE COMPLAINT OF AIR BUBBLES IN LINE CAN BE CONFIRMED BASED ON THE PHOTOS PROVIDED. HOWEVER, THE AIR BUBBLES IN THE PHOTOS WERE NOT DISTAL BELOW THE AIR FILTER. THE FILTER FEATURED IN THE PHOTO IS DESIGNED TO COLLECT ANY AIR BUBBLES AND NOT ALLOW THEM DOWN LINE. THE AIR FILTER IN THE PHOTO APPEARS TO BE FUNCTIONING AS DESIGNED. THE DEVICE SHOWED IN THE PICTURES WAS NOT RETURNED FOR EVALUATION. RECEIVED TWO NEW LN# 163359291 SAPPHIRE PRIMARY FILTER SETS. THE PRODUCT WAS ATTACHED TO AN ICU MEDICAL PROVIDED IV BAG, PRIMED PER PACKAGING DIRECTIONS AND A FLOW TEST WAS PERFORMED USING AN ICU SAPPHIRE PUMP. THERE WERE NO DIFFICULTIES IN PRIMING, NO OCCLUSION ALARMS WERE GENERATED. NO AIR IN LINE ALARMS WERE GENERATED. THERE WERE NO AIR BUBBLES FOUND WITHIN THE LINE DURING INFUSION. AFTER THE COMPLETED BAG HAD BEEN EMPTIED AND THE AIR REACHED THE PUMP THE INFUSIONS PAUSED, AN AIR IN LINE ALARM WAS GENERATED AND NO AIR BUBBLES WERE INFUSED DOWN LINE. THE RETURNED TWO NEW SAPPHIRE PRIMARY FILTER SET MET PRODUCT SPECIFICATIONS. D9 - DATE RETURNED TO MFG: 31-MAR-2021.

Additional Manufacturer Narrative

THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED.

Description of Event or Problem

THE EVENT INVOLVED A SAPPHIRE PRIMARY 1.2 MICRON FILTER SET, NON-VENTED, MICROBORE, 311 CM. IT WAS REPORTED THAT THE FILTER FILLED UP WELL DURING PRIMING BUT THEN EMPTIED WITHIN FIVE MINUTES, RESULTING IN THE PRESENCE OF LARGE AIR BUBBLES (SIZE > 5 CM IN THE TUBING) AFTER PASSING THROUGH THE FILTER. FURTHER, THE BUBBLES WERE SUBSEQUENTLY CAPTURED IN THE 1.2 MICRON PALL TNA FILTER WHICH WAS ADDED IN THE ASSEMBLY OF THE INFUSION LINE. THE PUMP DID NOT DISPLAY AN AIR ALARM BECAUSE THE SECOND FILTER SECURES THE LINE. THE CUSTOMER INDICATED THAT A PATIENT AT HIGH VITAL RISK WAS BEING INFUSED PARENTERAL NUTRITION (2900 ML TO BE INFUSED OVER 12 HOURS, ASCENT 1 HOUR, DESCENT 1 HOUR) ON SAPPHIRE PUMP VIA A CENTRAL VENOUS LINE AT THE PATIENT'S HOME. CONNECTION AND HANDLING WAS CHECKED BY THE NURSE; THE PROTOCOL WAS WELL FOLLOWED, HANDLING WAS CORRECT DURING PRIMING, THE TUBING WAS WELL INSERTED, AND THE PUMP WAS WELL SET UP. NO VISIBLE PHYSICAL DEFECT WAS NOTED ON THE SAMPLE. THERE WAS PATIENT INVOLVEMENT, HOWEVER, THERE WERE NO NEGATIVE CONSEQUENCES, NO DELAY IN CRITICAL THERAPY, NO BLOOD LOSS, NO REPORTED ADVERSE EVENT, AND NO HUMAN HARM.