CLEARLINK

Additional Manufacturer Narrative

G1: DEVICE MANUFACTURER ADDRESS 1: 600 MTS. OESTE DE ENTRADA, PRINCIPAL AVE. LAS AMERICAS, PARQUE INDUSTRIAL. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THAT THE INLINE PRESSURE PUMP OF TWO (2) CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SETS CRACKED. THIS OCCURRED WHILE SQUEEZING THE PUMP TO INFUSE FLUID. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

H11: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.