MEDEX

Description of Event or Problem

[REDACTED DATE] ESCALATED TO ICU MED/SMITHS MED FOR NOTIFICATION OF ISSUE. [REDACTED DATE] SITE REPORTS RECENT DESIGN CHANGE IN THIS PRODUCT. THIS PRODUCT HAD BEEN ON BACKORDER AND ALTERNATIVES WERE USED. WHEN THE PRODUCT RETURNED APPROXIMATELY 1.5 WEEKS AGO, THE CONNECTION DESIGN IS DIFFERENT. IF TIGHTENED TOO MUCH, THE CONNECTION IS STRIPPED. IF NOT TIGHT ENOUGH, IT LEAKS OR DISCONNECTS. EVENT #1 [REDACTED DATE]: DURING BEDSIDE REPORT DAY RN [REDACTED NAME] REPORTED LIPID PUMP WAS ALARMING DOWNSTREAM OCCLUSION PERIODICALLY THROUGHOUT THE DAY. TRACED THE LINE WITH PICC RN AND FOUND NO OCCLUSION OR KINK, ASPIRATED FROM Y-SITE CLOSEST TO THE PATIENT AND SLIGHTLY DIFFICULT AT FIRST BUT THEN FLOWED FINE. AROUND 2100 PUMP BEGAN ALARMING DOWNSTREAM OCCLUSION AGAIN. UPON VISUAL INSPECTION THE FILTER APPEARED ABNORMAL, ALMOST LIKE THERE WAS A TON OF AIR IN IT. LIPIDS IN TUBING DID NOT APPEAR TO BE MOVING PAST BIFUSE THEY WERE ATTACHED TO WITH TPN, EVEN AFTER CLAMPING TPN. LINE CHANGE PERFORMED AND NEW BAG HUNG. DISCONNECTED OLD LIPID FILTER FROM TUBING AND AIR AND LIPIDS CAME SHOOTING OUT OF THE FILTER WITH A LOT OF PRESSURE. ATTACHED A 3ML SYRINGE TO THE END OF THE FILTER AND TRIED TO FLUSH THROUGH 2ML AIR, TOOK SEVERAL ATTEMPTS OF IT BOUNCING BACK AND INCREASED FORCE BEFORE IT WOULD PUSH THROUGH. FILTER SAVED AT BEDSIDE FOR APSMS, PICTURE OF FILTER EMAILED TO APSM. AS OF THIS WRITING, NEW FILTER APPEARS NORMAL, LIPIDS VISUALIZED RUNNING THROUGH THE ENTIRETY OF THE LINE, AND PUMP HAS NOT READ OCCLUSION. EVENT #2 [REDACTED DATE]: AROUND 11AM RN NOTICED A LARGE WET SPOT ON BED LINENS. LEAKING NOTED TO BE SMOF LIPIDS. THE LEAKING OCCURRED WHERE THE LIPID FILTER CONNECTED TO THE ANTI-SIPHON VALVE AT THE TRIFUSE. DUE TO THIS FINDING THE LINE WAS NOW COMPROMISED AND THE TPN, SMOF LIPIDS, AND CENTRAL LINE TUBING NEEDED TO BE DISCARDED AND NEW TUBING AND FLUIDS HAD TO BE HUNG. EVENT #3 [REDACTED DATE]: LIPIDS LEAKING AT CONNECTION BETWEEN REGULAR BAXTER IV TUBING AND MEDEX MICRON LIPID FILTER. EVENT #4 [REDACTED DATE]: LIPIDS STARTED LEAKING WHERE THE REGULAR IV TUBING MEETS THE LIPID FILTER ON A PCVC LINE. MANUFACTURER RESPONSE FOR LIPID FILTER (IV), (BRAND NOT PROVIDED) (PER SITE REPORTER) E-MAIL SENT TO ICU MED REPS ON [REDACTED DATE], AWAITING RESPONSE.