CLEARLINK

Additional Manufacturer Narrative

ADDITIONAL INFORMATION WAS ADDED TO H4 AND H6. H11: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. IT WAS OBSERVED THAT ALL COMPONENTS WERE CORRECTLY INSTALLED AND IN ACCORDANCE WITH SPECIFICATIONS. THE SAMPLE WAS THEN SUBMITTED TO PRESSURE TESTING AND CLEAR PASSAGE TESTING, AND NO LEAK OR BLOCKAGE WAS NOTED IN THE SET. THE REPORTED CONDITION WAS NOT VERIFIED IN THE COMPANION SAMPLE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT AN UNSPECIFIED AMOUNT OF CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS WERE CAUSING LOADING ISSUES WITH THE NOVUM IQ PUMP. THE LOADING ERROR WAS AT THE AIR BUBBLE SENSOR (SENSOR NUMBER 2). THE DEVICE CONTAINED SALINE. THIS WAS OBSERVED DURING SETUP. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

E1: INITIAL REPORTER PHONE NO.: (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.