2008K@HOME HEMODIALYSIS SYSTEM

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HOME HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) NEGLECTED TO OPEN THE HEPARIN LINE CLAMP PRIOR TO TREATMENT AND THE PATIENT¿S EXTRACORPOREAL CIRCUIT ¿COAGULATED.¿ THE PATIENT ALLEGED THE 2008K@HOME HEMODIALYSIS SYSTEM DID NOT ALARM THAT THE HEPARIN LINE WAS CLAMPED, AND THEREFORE THE PATIENT WAS REQUIRED TO TERMINATE TREATMENT EARLY. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) FOR THIS TREATMENT IS APPROXIMATELY 325 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. AN INSPECTION OF THE MACHINE AFTER THE EVENT REVEALED THE HEPARIN PUMP REQUIRED REPLACEMENT DUE TO SIGNS OF ¿KINKING.¿ A NEW HEPARIN PUMP WAS INSTALLED AND DURING FOLLOW-UP RESTRAINT TESTING, THE 2008K@HOME HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY. ADDITIONALLY, IT WAS REPORTED ALL POST EVENT FUNCTIONAL COMPLIANCE CHECKS WERE PASSED.

Additional Manufacturer Narrative

CORRECTION: G2 ADDITIONAL INFORMATION: A1, A3, A4, B5 (ESTIMATED BLOOD LOSS), D9, H3 PLANT INVESTIGATION: NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONALLY, NO ON-SITE EVALUATION WAS PERFORMED BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST). A RECORDS REVIEW WAS PERFORMED ON THE REPORTED SERIAL NUMBER. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO NON-CONFORMANCES, OR ANY ASSOCIATED REWORK IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE RELATED TO THE REPORTED EVENT. IN ADDITION, THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE INVESTIGATION INTO THE CAUSE OF THE REPORTED PROBLEM WAS NOT ABLE TO BE CONFIRMED. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED WITHOUT A PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.  CLINICAL INVESTIGATION: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING THE 2008K@HOME HEMODIALYSIS SYSTEM AND THE ADVERSE EVENTS OF THE EXTRACORPOREAL CIRCUIT COAGULATING, RESULTING IN BLOOD LOSS (300 ML) AND THE EARLY TERMINATION OF TREATMENT. CAUSALITY IS ATTRIBUTED TO THE PATIENT NEGLECTING TO OPEN THE HEPARIN LINE CLAMP PRIOR TO INITIATING TREATMENT. HOWEVER, THE 2008K@HOME HEMODIALYSIS SYSTEM FAILED TO ALARM AS EXPECTED GIVEN THE HEPARIN LINE WAS BLOCKED, WHICH PREDISPOSED THE EXTRACORPOREAL CIRCUIT TO COAGULATION. WHILE UNDERGOING HD THERAPY, BLOOD TRAVELING THROUGH THE EXTRACORPOREAL CIRCUIT HAS AN INCREASED RISK FOR CLOTTING, AND THE INTRODUCTION OF HEPARIN IS RECOMMENDED TO LESSEN THE POSSIBILITY. BASED ON THE INFORMATION AVAILABLE, THE 2008K@HOME HEMODIALYSIS SYSTEM CANNOT BE EXCLUDED FROM HAVING AN ¿INDIRECT¿ CAUSAL OR CONTRIBUTORY ROLE IN THE EVENTS. GIVEN THE 2008K@HOME HEMODIALYSIS SYSTEM FAILED TO RECOGNIZE THE HEPARIN LINE REMAINED CLAMPED, AND THE REPLACEMENT OF THE HEPARIN PUMP DUE TO SIGNS OF KINKING, THERE IS INSUFFICIENT EVIDENCE TO DISASSOCIATE THE FRESENIUS PRODUCT(S) OR DEVICE(S) UTILIZED BY THE PATIENT.

Description of Event or Problem

IT WAS REPORTED TO FRESENIUS THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON HOME HEMODIALYSIS (HD) FOR RENAL REPLACEMENT THERAPY (RRT) NEGLECTED TO OPEN THE HEPARIN LINE CLAMP PRIOR TO TREATMENT AND THE PATIENT¿S EXTRACORPOREAL CIRCUIT ¿COAGULATED.¿ THE PATIENT ALLEGED THE 2008K@HOME HEMODIALYSIS SYSTEM DID NOT ALARM THAT THE HEPARIN LINE WAS CLAMPED, AND THEREFORE THE PATIENT WAS REQUIRED TO TERMINATE TREATMENT EARLY. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) FOR THIS TREATMENT IS APPROXIMATELY 300 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY, ADVERSE EVENT, OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED EVENT. AN INSPECTION OF THE MACHINE AFTER THE EVENT REVEALED THE HEPARIN PUMP REQUIRED REPLACEMENT DUE TO SIGNS OF ¿KINKING.¿ A NEW HEPARIN PUMP WAS INSTALLED AND DURING FOLLOW-UP RESTRAINT TESTING, THE 2008K@HOME HEMODIALYSIS SYSTEM ALARMED APPROPRIATELY. ADDITIONALLY, IT WAS REPORTED ALL POST EVENT FUNCTIONAL COMPLIANCE CHECKS WERE PASSED.