D130 PH.I.S.I.O. DIDECO KIDS NEONATAL ARTERIAL FILTER W/40 MICRON SCREEN PHOSPHO

Additional Manufacturer Narrative

SORIN GROUP(B)(4) MANUFACTURES THE D130 PH.I.S.I.O. DIDECO KIDS NEONATAL ARTERIAL FILTER W/40 MICRON SCREEN PHOSPHOSPHORYLCHOLINE COATED. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT THE OUTLET PORT OF THE DIDECO KIDS NEONATAL ARTERIAL FILTER WAS FOUND TO BE BROKEN OFF DURING SET UP. THE FILTER WAS REPLACED AND THE PROCEDURES WAS COMPLETED WITH NO FURTHER ISSUES. THERE WAS NO PATIENT INVOLVEMENT. THE FILTER WAS RETURNED TO SORIN GROUP USA FOR EVALUATION. VISUAL INSPECTION OF THE FILTER CONFIRMED THE BLOOD OUTLET PORT WAS BROKEN OFF AT THE BASE. INSPECTION UNDER ULTRA VIOLET LIGHT SHOWED EVIDENCE OF SOLVENT BONDING OF THE PORT, BUT NO EVIDENCE OF EXCESS SOLVENT OR POOLING WAS SEEN. NO SIGNIFICANT WHITENING OR DEFORMATION WAS OBSERVED IN THE MATERIAL AT THE BREAK SITE. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY DEVIATIONS OR NONCONFORMITIES RELATED TO THE FAILURE. THE TUBING TO CONNECTOR PROCESSES AT SORIN GROUP (B)(4) AND SORIN GROUP USA ARE BEING EVALUATED AND A CAPA PROJECT HAS BEEN OPENED TO DETERMINE THE ROOT CAUSE OF THE FAILURE AND IDENTIFY APPROPRIATE CORRECTIVE ACTIONS.

Description of Event or Problem

SORIN GROUP RECEIVED A REPORT THAT THE OUTLET PORT OF THE DIDECO KIDS NEONATAL ARTERIAL FILTER WAS FOUND TO BE BROKEN OFF DURING SET UP. THE FILTER WAS REPLACED AND THE PROCEDURE WAS COMPLETED WITH NO FURTHER ISSUE. THERE WAS NO PATIENT INVOLVEMENT.