FLUID SYSTEMS ACCESSORIES

Additional Manufacturer Narrative

D4 UDI: AS THE LOT # IS UNKNOWN, THE UDI WILL CONSIST OF THE PRIMARY DI NUMBER ONLY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AIR WAS OBSERVED IN A AIR ELIMINATING 1.2 MICROMETER SOLUTION FILTER CONNECTED TO A BAXTER EXTENSION SET. THE ISSUE WAS IDENTIFIED WHILE THE REGISTERED NURSE WAS PRIMING THE LINE ON THE INFUSION PUMP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H6 AND H11. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.