CADD INFUSION DISPOSABLES PORTFOLIO WITH NRFIT

Description of Event or Problem

INFORMATION RECEIVED A SMITHS MEDICAL AMBULATORY INFUSION PUMPS/CADD CASSETTE RESERVOIRS - FLOW STOP MALFUNCTIONED.. REPORTED DURING THE USE OF THE PRODUCT ,MEDICAL FLUID LEAKED FROM IT. NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD REVIEW. SIX SAMPLES WERE RECEIVED DECONTAMINATED INSIDE A PLASTIC BAG WITH ITS ORIGINAL OPEN PACKAGE. VISUAL INSPECTION WAS PERFORMED AT 12 TO 16 INCHES UNDER NORMAL CONDITIONS OF ILLUMINATION. DURING THE FUNCTIONAL TESTING, THE SAMPLES WERE TESTED FOR LEAKS BY PASSING WATER THROUGH IT; LEAKS WERE DETECTED IN THE LUER. THE COMPLAINT WAS CONFIRMED. THE ROOT CAUSE WAS RELATED TO THE USE OF AN INADEQUATE USED IN THE OPERATION. CHANGED THE TYPE OF SOLVENT DISPENSER, BECAUSE IT WAS IDENTIFIED IS NOT THE APPROPRIATE FOR THIS ASSEMBLY.