MICRO-VOLUME EXTENSION SET

Additional Manufacturer Narrative

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT A NON-DEHP MICRO-VOLUME EXTENSION SET WHILE BEING USED WITH UNSPECIFIED PUMP PRESENTED A DOWNSTREAM OCCLUSION ALARM. THIS WAS IDENTIFIED DURING USE. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H10: THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, A COMPANION SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. FUNCTIONAL TESTS WERE PERFORMED WHICH INCLUDED A PRESSURE TEST WITH NO LEAK OBSERVED AND A PULL TEST WITH NO SEPARATION NOTED. THE REPORTED CONDITION WAS NOT VERIFIED ON 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