COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

H3 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS NOT RETURNED TO THE MANUFACTURER. SINCE THE COMPLAINT SAMPLE IS NOT AVAILABLE FOR EVALUATION, THE REPORTED EVENT CANNOT BE CONFIRMED. THE DEVICE HISTORY RECORD [DHR] OF THIS PRODUCT WAS REVIEWED AND NO NONCONFORMANCE REPORTS OR OTHER ABNORMALITIES DURING THE ASSEMBLY OF THIS LOT WERE FOUND. THE PRODUCT INVOLVED WAS RELEASED MEETING SPECIFICATIONS. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT CANNOT BE REACHED.

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE MANUFACTURER IS PENDING THE RETURN OF THE SAMPLE FOR PHYSICAL EVALUATION. A PRELIMINARY INVESTIGATION OF QUALITY RECORDS WAS COMPLETED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. THERE WERE NO NON-CONFORMANCES OR ABNORMALITIES IDENTIFIED DURING THE MANUFACTURING PROCESS WHICH COULD BE ASSOCIATED WITH THE REPORTED EVENT. THE ENTIRE LOT HAS BEEN SOLD AND DISTRIBUTED. IN ADDITION, A DEVICE HISTORY REVIEW WAS PERFORMED AND CONFIRMED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. THE LOT MET ALL SPECIFICATIONS FOR RELEASE. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. A DEFINITIVE CONCLUSION REGARDING THE COMPLAINT INCIDENT IS PENDING THE RETURN OF THE COMBI SET AND A PHYSICAL EVALUATION.

Description of Event or Problem

A USER FACILITY BIOMEDICAL TECHNICIAN REPORTED A BLOOD LEAK THAT OCCURRED WITH A COMBI SET AT THE BEGINNING OF THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED BY THE NURSING STAFF. THE 2008T MACHINE TREATING THE PATIENT ALSO ALARMED. THE BIOMEDICAL TECHNICIAN STATED THAT A RED CONNECTOR ON THE TUBING OF THE COMBI SET DID NOT APPEAR TO BE PROPERLY GLUED. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 100 ML. THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.