SECNDRY SET 34IN NDEHP W/EXT HOOK

Additional Manufacturer Narrative

SUBSEQUENT TO THE SUBMISSION OF INITIAL MEDWATCH MFR REPORT #9615050-2012-01457 IT WAS NOTED THE MANUFACTURER REPORT # FOR (B)(4) WAS INADVERTENTLY SELECTED INSTEAD OF THE INTENDED (B)(4) MANUFACTURER#.

Description of Event or Problem

THE CUSTOMER CONTACT REPORTED NO FLOW. ON AN UNSPECIFIED DATE, THE PRIMARY TUBING SET WAS BEING USED TO DELIVER AN UNSPECIFIED MEDICATION, AT AN UNSPECIFIED RATE, VIA A PUMP. AFTER AN UNSPECIFIED LENGTH OF TIME, THE OPTION-LOK MALE ADAPTER OF THE PRIMED SECONDARY TUBING SET WAS CONNECTED TO THE PROXIMAL NEEDLELESS VALVE CONNECTOR Y-SITE ON THE PRIMARY TUBING SET FOR PIGGYBACK DELIVERY OF AN UNSPECIFIED ANTIBIOTIC. IT WAS REPORTED THAT THE PRIMARY SOLUTION CONTAINER WAS HUNG LOWER THAN THE SECONDARY SOLUTION CONTAINER. IT WAS REPORTED THAT AFTER THE PIGGYBACK DELIVERY WAS STARTED, NO FLOW OF SOLUTION WAS NOTED. THE CUSTOMER CONTACT REPORTED THAT THE NURSE LOWERED THE PRIMARY SOLUTION CONTAINER FURTHER; HOWEVER, NO FLOW OF SOLUTION WAS AGAIN NOTED. IT WAS REPORTED THAT THE OPTION-LOK MALE ADAPTER OF THE SECONDARY TUBING SET WAS DISCONNECTED FROM THE PROXIMAL NEEDLELESS VALVE CONNECTOR Y-SITE ON THE PRIMARY TUBING SET AND RECONNECTED TO PROXIMAL NEEDLELESS VALVE CONNECTOR Y-SITE ON THE PRIMARY TUBING SET. NO FLOW OF SOLUTION WAS AGAIN NOTED. IT WAS REPORTED THE PRIMARY TUBING SET WAS CLAMPED AND THE PUMP ALARMED FOR AN UNSPECIFIED OCCLUSION. AFTER AN UNSPECIFIED LENGTH OF TIME, IT WAS REPORTED THE PIGGYBACK SOLUTION FLOWED. THE TUBING SET REMAINED IN CLINICAL USE AND THE THERAPY WAS RESUMED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED DELAYS IN THERAPY CRITICAL TO THIS PATIENT. NO MEDICAL INTERVENTIONS WERE REQUIRED. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.