MEDEX FILTER SET

Description of Event or Problem

IT WAS REPORTED THAT THE IV FLUID IS NOT RUNNING THROUGH THE ADMINISTRATION SET. THERE WAS NO PATIENT INJURY REPORTED.

Additional Manufacturer Narrative

ONE FILTER SET WAS RECEIVED FOR EVALUATION IN RELATION TO THE REPORTED EVENT. EVALUATION OF THE DEVICE IS CURRENTLY IN PROGRESS. ONCE THE EVALUATION IS COMPLETE, A FOLLOW-UP REPORT WITH EVALUATION RESULTS WILL BE SUBMITTED.

Additional Manufacturer Narrative

OTHER TEXT: THIS MDR WAS GENERATED UNDER PROTOCOL (B)(4), AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. SAMPLE WENT THROUGH WATER LEAK AND OCCLUSION TEST AND IT DID NOT EXHIBIT LEAKAGE OR OCCLUSION CONDITION. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED, AS THE RETURNED SAMPLE DID NOT EXHIBITED OCCLUSION NOR DEFECTIVE CONDITION. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW.

Additional Manufacturer Narrative

THIS MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS# (B)(4). A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. SAMPLE WENT THROUGH WATER LEAK AND OCCLUSION TEST AND IT DID NOT EXHIBIT LEAKAGE OR OCCLUSION CONDITION. THE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED, AS THE RETURNED SAMPLE DID NOT EXHIBITED OCCLUSION NOR DEFECTIVE CONDITION. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: AWARENESS MEETING WITH OPERATORS AND QUALITY INSPECTORS ABOUT THE FAILURE MODE REPORTED ON THIS COMPLAINT WAS HELD. NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DEVICE HISTORY RECORD REVIEW.