CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE CLIC BLOOD CHAMBER WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE DEVICE WAS RETURNED WITHOUT ITS ORIGINAL PACKAGING. DURING VISUAL INSPECTION OF THE DEVICE, NO DAMAGE WAS IDENTIFIED. THE SAMPLE WAS TESTED DURING A SIMULATED TREATMENT THAT WAS PERFORMED ON A 2008K HEMODIALYSIS (HD) MACHINE. THE CLIC BLOOD CHAMBER WAS CONNECTED TO A COMBI SET AND DIALYZER, AND A MAHURKAR 11.5 FR DUAL LUMEN CATHETER WAS ATTACHED TO THE ARTERIAL AND VENOUS LINES TO MAINTAIN A CONSTANT RESTRICTION. THE SAMPLE WAS TESTED FOR A PERIOD OF FOUR HOURS. THERE WERE NO DISCONNECTIONS, LEAKS, OR AIR BUBBLES FOUND INSIDE THE SYSTEM DURING TESTING. IN ADDITION, THERE WAS NO LEVEL VARIATION OF THE VENOUS AND ARTERIAL CHAMBERS. NO ABNORMALITIES WERE IDENTIFIED DURING THE SIMULATED TREATMENT. A MANUFACTURING REVIEW WAS PERFORMED FOR ALL CRIT-LINE CLIC BLOOD CHAMBERS SHIPPED TO THE ACCOUNT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS AND SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. UPON COMPLETION OF THE EVALUATION, THERE WERE NO MALFUNCTIONS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE CLIC BLOOD CHAMBER PERFORMED AS DESIGNED AND AN ASSOCIATED CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS UNDERGOING HD THERAPY WHEN A BLOOD LEAK OCCURRED. TWO HOURS AND FORTY-FIVE MINUTES INTO THE PATIENT'S TREATMENT, THE REGISTERED NURSE (RN) NOTICED BLOOD LEAKING FROM THE TOP OF THE HEMOFLOW F3 DIALYZER (WHERE THE CRIT-LINE DEVICE CONNECTS TO THE DIALYZER). THE ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THE PATIENT¿S HD TREATMENT WAS STOPPED, AND THE RN ATTEMPTED TO RETURN THE PATIENT¿S BLOOD. WHILE RETURNING THE BLOOD, THE PATIENT¿S CENTRAL VENOUS CATHETER LINE CLOTTED (TREATED WITH CATHFLO, GOOD EFFECT), AND APPROXIMATELY 64 ML OF BLOOD COULD NOT BE RETURNED (APPROXIMATE TOTAL EBL = 84 ML). A COMPLETE BLOOD COUNT (CBC) WAS OBTAINED, WHICH REVEALED THE PATIENT¿S HEMOGLOBIN WAS 7.1 GM/DL AND HEMATOCRIT WAS 19.9%. THE DIALYZER WAS REPORTEDLY SEQUESTERED AND STORED FOR EVALUATION/TESTING. AS A RESULT OF THE LEAK, THE NEPHROLOGIST ORDERED ONE UNIT OF PEDIATRIC PACKED RED BLOOD CELLS (150 ML) TO BE ADMINISTERED AT THE NEPHROLOGY CLINIC ON (B)(6) 2021. THE PATIENT WAS TRANSFUSED WITHOUT ISSUE, AND REPEAT LABS SHOWED THE PATIENT¿S HEMOGLOBIN ROSE TO 11.6 GM/DL AND THE HEMATOCRIT ROSE TO 35.7%. IN ADDITION TO THE UNIT OF BLOOD, THE FOLLOWING CHANGES WERE MADE TO THE PATIENT¿S THRICE WEEKLY HD TREATMENTS. THE PATIENT¿S HEPARIN BOLUS WAS INCREASED FROM 200 UNITS TO 220 UNITS, THE HOURLY HEPARIN WAS INCREASED FROM 100 UNITS TO 110 UNITS, AND THE DIALYZER WAS CHANGED FROM AN F3 TO 6H POLYFLUX. THE PATIENT HAS RECOVERED FROM THE EVENT AND HAS CONTINUED TO UNDERGO HD THERAPY FOR RRT. THE DIALYZER WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER AND THE LOT NUMBER WAS NOT PROVIDED. A MANUFACTURING REVIEW WAS PERFORMED FOR ALL CRIT-LINE CLIC BLOOD CHAMBERS SHIPPED TO THE ACCOUNT FOR THE THREE (3) MONTH TIME FRAME WHICH IMMEDIATELY PRECEDED THE EVENT OCCURRENCE DATE. THE ENTIRE SET OF LOTS HAVE BEEN SOLD AND DISTRIBUTED. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. AN INVESTIGATION OF THE DEVICE HISTORY RECORDS (DHR) CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS AND SPECIFICATIONS FOR RELEASE. A REVIEW OF THE DHR DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED. CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING THE HEMOFLOW F3 DIALYZER AND THE SERIOUS ADVERSE EVENT OF BLOOD LOSS FROM A BLOOD LEAK WHICH PROMPTED A BLOOD TRANSFUSION OF 150 ML AND A CHANGE IN DIALYZERS. THE REPORTER DID NOT DESCRIBE ANY DEFECT(S) OR DAMAGE PRIOR TO THE LEAK BEING DISCOVERED. HOWEVER, EVIDENCE OF A DIALYZER BLOOD LEAK WAS CONFIRMED BY THE VISUALIZATION OF BLOOD OUTSIDE THE HEMOFLOW F3 DIALYZER, WHERE THE CRIT-LINE DEVICE CONNECTS TO THE DIALYZER (EBL = 84 ML). WHILE UNCOMMON, BLOOD LEAK EVENTS ARE A KNOWN POTENTIAL COMPLICATION OF UTILIZING HEMOFLOW SERIES DIALYZERS DURING HD THERAPY. BASED ON THE TOTALITY OF THE INFORMATION AVAILABLE, THE LIBERTY SELECT CYCLER CANNOT BE EXCLUDED FROM HAVING A POSSIBLE CAUSAL AND/OR CONTRIBUTORY ROLE IN THE PATIENT¿S BLOOD LOSS EVENT. IF THE HEMOFLOW F3 DIALYZER IS RETURNED, A MANUFACTURER EVALUATION MAY DISSOCIATE THE PRODUCT FROM HAVING CAUSED AND/OR CONTRIBUTED TO THE SERIOUS ADVERSE EVENT. HOWEVER, WITHOUT MORE INFORMATION THIS CLINICAL INVESTIGATION CANNOT DISASSOCIATE THE PRODUCT FROM THE EVENT.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT A PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) WAS UNDERGOING HD THERAPY WHEN A BLOOD LEAK OCCURRED. TWO HOURS AND FORTY-FIVE MINUTES INTO THE PATIENT'S TREATMENT, THE REGISTERED NURSE (RN) NOTICED BLOOD LEAKING FROM THE TOP OF THE HEMOFLOW F3 DIALYZER (WHERE THE CRIT-LINE DEVICE CONNECTS TO THE DIALYZER). THE ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20 ML. THE PATIENT¿S HD TREATMENT WAS STOPPED, AND THE RN ATTEMPTED TO RETURN THE PATIENT¿S BLOOD. WHILE RETURNING THE BLOOD, THE PATIENT¿S CENTRAL VENOUS CATHETER LINE CLOTTED (TREATED WITH CATHFLO, GOOD EFFECT), AND APPROXIMATELY 64 ML OF BLOOD COULD NOT BE RETURNED (APPROXIMATE TOTAL EBL = 84 ML). A COMPLETE BLOOD COUNT (CBC) WAS OBTAINED, WHICH REVEALED THE PATIENT¿S HEMOGLOBIN WAS 7.1 GM/DL AND HEMATOCRIT WAS 19.9%. THE DIALYZER WAS REPORTEDLY SEQUESTERED AND STORED FOR EVALUATION/TESTING. AS A RESULT OF THE LEAK, THE NEPHROLOGIST ORDERED ONE UNIT OF PEDIATRIC PACKED RED BLOOD CELLS (150 ML) TO BE ADMINISTERED AT THE NEPHROLOGY CLINIC ON 15/JUN/2021. THE PATIENT WAS TRANSFUSED WITHOUT ISSUE, AND REPEAT LABS SHOWED THE PATIENT¿S HEMOGLOBIN ROSE TO 11.6 GM/DL AND THE HEMATOCRIT ROSE TO 35.7%. IN ADDITION TO THE UNIT OF BLOOD, THE FOLLOWING CHANGES WERE MADE TO THE PATIENT¿S THRICE WEEKLY HD TREATMENTS. THE PATIENT¿S HEPARIN BOLUS WAS INCREASED FROM 200 UNITS TO 220 UNITS, THE HOURLY HEPARIN WAS INCREASED FROM 100 UNITS TO 110 UNITS, AND THE DIALYZER WAS CHANGED FROM AN F3 TO 6H POLYFLUX. THE PATIENT HAS RECOVERED FROM THE EVENT AND HAS CONTINUED TO UNDERGO HD THERAPY FOR RRT. THE DIALYZER WAS REPORTEDLY AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.