MEDEX IV FILTER EXTENSION SET

Additional Manufacturer Narrative

EVALUATION CODES: UPDATED. DEVICE EVALUATION: NO PRODUCT SAMPLE NOR PICTURES WERE RECEIVED FOR ANALYSIS; THEREFORE, VISUAL AND FUNCTIONAL TESTING COULD NOT BE PERFORMED. THE REPORTED ISSUE COULD NOT BE CONFIRMED. NO LOT NUMBER HAS BEEN PROVIDED, THEREFORE NO DEVICE HISTORY REPORT (DHR) REVIEW COULD BE PERFORMED. IF THE PRODUCT IS RETURNED, THE MANUFACTURER WILL REOPEN THIS COMPLAINT FOR FURTHER INVESTIGATION.

Additional Manufacturer Narrative

D4: LOT NUMBER, FULL UDI NUMBER, EXPIRATION DATE, AND H4: MANUFACTURE DATE ARE UNKNOWN; NO INFORMATION HAS BEEN PROVIDED TO DATE. H3 - OTHER: DEVICE HAS NOT BEEN RETURNED TO DATE. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE.

Description of Event or Problem

IT WAS REPORTED THAT THERE WAS "A TREND OF MALFUNCTIONING FILTER MICROBORE INTRAVENOUS INFUSION TUBING THAT BEGAN STARTING 2023. THE TUBING LEAKS AT THE FILTER OR REQUIRES EXCESS PRESSURE TO PRIME/INFUSE FLUID. HAS IMPACTED FLOW OF MEDICATIONS SUCH AS INOTROPES AND SEDATION ON CRITICALLY ILL PEDIATRIC CARDIOVASCULAR PATIENTS IN THE OPERATING ROOM OR INTENSIVE CARE UNIT. ONE PATIENT IN 2023 HAD EPINEPHRINE LEAKING IN THE OPERATING ROOM DURING OPEN HEART SURGERY, POSSIBLY CONTRIBUTING TO A DELAY IN COMING OFF OF BYPASS. RE-ESCALATED TO THE MANUFACTURER ON THAT DAY, AND THEY CAME ON SITE 2023 TO RETRIEVE PRODUCT. AT THAT TIME, THEY MENTIONED THAT THE FILTER IS PROVIDED BY ANOTHER COMPANY. HAVE NOT STOPPED USE OF THE PRODUCT BUT HAVE RE-EDUCATED STAFF ON THE MANUFACTURER'S INSTRUCTIONS FOR USE WITH ONGOING ISSUE." THERE WAS NO PATIENT HARM REPORTED. NO PATIENT NAMES AVAILABLE. PRODUCT FAILURES OCCURRED DURING INFUSION, NOTICED HOURS OR DAYS INTO INFUSION.