CLEARLINK

Additional Manufacturer Narrative

CORRECTED INFORMATION: B1, B2, B5, D5, D10 F10, AND H1. B5: THE PATIENT UNDERWENT AN EMERGENCY REPAIR OF THE ASCENDING AORTA WITH GRAFTING, CORONARY ARTERY BYPASS GRAFT, AND CYSTOSCOPY WITH SUPRAPUBIC CATHETER PLACEMENT. WHEN THE ANESTHESIOLOGIST WENT TO UTILIZE THE CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET IN CONJUNCTION WITH AN UNKNOWN HAND PUMP, BLOOD LEAKED FROM ¿THE AREA WHERE THE PUMP CONNECTS WITH THE CHAMBER¿. WHEN PRESSURE WAS APPLIED TO THE PUMP, BLOOD SPRAYED OUT. BOTH DONATED AND AUTOLOGOUS BLOOD WERE USED. THE VOLUME OF BLOOD LOSS WAS NOT REPORTED; NOR WAS IT REPORTED IF ANY MEDICAL INTERVENTION WAS INITIATED. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

Description of Event or Problem

IT WAS REPORTED THAT A CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS LEAKING FROM THE AREA WHERE THE HAND PUMP CONNECTS WITH THE CHAMBER. IN THIS EVENT, BLOOD LEAKED THROUGH THE TOP OF THE HAND SQUEEZED PUMP. THE PRESSURE APPLIED TO THE PUMP SPRAYED BLOOD AROUND THAT SIDE OF THE ANESTHESIA/OPERATING ROOM AREA. THE PUMP WAS USED WITH BOTH DONATED BLOOD AND AUTOLOGOUS BLOOD. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

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.

Additional Manufacturer Narrative

CORRECTION: B1, H1 ADDITIONAL INFORMATION: B5, H4, H6 AND H11. B5: UPON ADDITIONAL INFORMATION, THE LEAKING BLOOD WAS FOUND TO BE FROM THE CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WHICH WAS CONNECTED TO TRANSFUSED BLOOD AND NOT FROM THE PATIENT. THEREFORE, THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. H11: BASED ON ADDITIONAL INFORMATION RECEIVED, CLEARLINK SYSTEM Y-TYPE BLOOD/SOLUTION SET WAS DETERMINED NOT TO BE A FACTOR IN THE REPORTED ADVERSE EVENT. 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.