COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

CORRECTION: G3 (DATE RECEIVED): THE DATE RECEIVED ON THE INITIAL MDR SUBMISSION WAS INDICATED AS 7/09/2025. THE CORRECT DATE RECEIVED IS 7/10/2025.

Description of Event or Problem

THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE VENOUS LINE BROKE OFF FROM THE TWIST DURING THE MIDDLE OF PATIENT TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW-UP. THE REPORTED ISSUE WAS DISCOVERED UPON COMPLETION OF THE PATIENT'S THREE-HOUR TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED. NO ALARMS WERE RECEIVED ON THE 2008T MACHINE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE ISSUE AND/OR MAY HAVE CAUSED THE MACHINE TO ALARM. NO LOOSE CONNECTION, DEFECT, OR DAMAGE WAS NOTED TO THE BLOODLINES PRIOR TO THE EVENT. ADDITIONALLY NO ISSUES WERE ENCOUNTERED WHILE PRIMING THE SETUP FOR THIS TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 700 ML. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AS A PRECAUTIONARY MEASURE. TESTING WAS CARRIED OUT UPON ADMISSION, PRESUMABLY TO ASCERTAIN ANY LEVEL OF ANEMIA OR ADVERSE EFFECTS ATTRIBUTED TO THE BLOOD LOSS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY AND PROVIDED A WHOLE BLOOD TRANSFUSION WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY DUE TO THE BLOOD LOSS.

Description of Event or Problem

THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE VENOUS LINE BROKE OFF FROM THE TWIST DURING THE MIDDLE OF PATIENT TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW-UP. THE REPORTED ISSUE WAS DISCOVERED UPON COMPLETION OF THE PATIENT'S THREE-HOUR TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED. NO ALARMS WERE RECEIVED ON THE 2008T MACHINE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE ISSUE AND/OR MAY HAVE CAUSED THE MACHINE TO ALARM. NO LOOSE CONNECTION, DEFECT, OR DAMAGE WAS NOTED TO THE BLOODLINES PRIOR TO THE EVENT. ADDITIONALLY NO ISSUES WERE ENCOUNTERED WHILE PRIMING THE SETUP FOR THIS TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 700 ML. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AS A PRECAUTIONARY MEASURE. TESTING WAS CARRIED OUT UPON ADMISSION, PRESUMABLY TO ASCERTAIN ANY LEVEL OF ANEMIA OR ADVERSE EFFECTS ATTRIBUTED TO THE BLOOD LOSS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY AND PROVIDED A WHOLE BLOOD TRANSFUSION WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY DUE TO THE BLOOD LOSS.

Additional Manufacturer Narrative

CORRECTION: G3 (DATE RECEIVED): THE DATE RECEIVED ON THE INITIAL MDR SUBMISSION WAS INDICATED AS 7/11/2025. THE CORRECT DATE RECEIVED IS 7/10/2025.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE COMPLAINT SAMPLE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AS THE COMPLAINT PRODUCT SAMPLE WAS DISINFECTED AND PREPARED FOR ANALYSIS, A LEAK WAS FOUND CAUSED BY A SEPARATION IN THE ARTERIAL MAIN LINE ASSEMBLED TO THE TWISTER. DURING A VISUAL INSPECTION IT WAS OBSERVED THAT THE ARTERIAL TWISTER PORT ASSEMBLED TO THE ARTERIAL MAIN LINE WAS BROKEN. AFTER FURTHER INSPECTION, NO OTHER PROBLEMS WERE FOUND. FURTHERMORE, TWO IMAGES FROM THE CLINIC WERE RECEIVED; BASED ON WHAT WAS SEEN IN THEM, IT WAS VERIFIED THAT THE TOP PORT TO VENOUS LINE OF THE TWISTER WAS BROKEN. THE REPORTED ISSUE WAS CONFIRMED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE INVOLVED LOT OF THE PRODUCT AND THERE WERE NO NON-CONFORMANCES, DEVIATIONS OR ANY ASSOCIATED REWORK RELATED WITH THE ALLEGED FAILURE MODE DURING THE ASSEMBLY PROCESS OF THE LOT INVOLVED. ALL THE APPLICABLE IN-PROCESS AND FINAL INSPECTION TESTS WERE FOUND WITH ACCEPTABLE RESULTS.

Description of Event or Problem

THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE VENOUS LINE BROKE OFF FROM THE TWIST DURING THE MIDDLE OF PATIENT TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW-UP. THE REPORTED ISSUE WAS DISCOVERED UPON COMPLETION OF THE PATIENT'S THREE-HOUR TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED. NO ALARMS WERE RECEIVED ON THE 2008T MACHINE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE ISSUE AND/OR MAY HAVE CAUSED THE MACHINE TO ALARM. NO LOOSE CONNECTION, DEFECT, OR DAMAGE WAS NOTED TO THE BLOODLINES PRIOR TO THE EVENT. ADDITIONALLY, NO ISSUES WERE ENCOUNTERED WHILE PRIMING THE SETUP FOR THIS TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 700 ML. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AS A PRECAUTIONARY MEASURE. TESTING WAS CARRIED OUT UPON ADMISSION, PRESUMABLY TO ASCERTAIN ANY LEVEL OF ANEMIA OR ADVERSE EFFECTS ATTRIBUTED TO THE BLOOD LOSS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY AND PROVIDED A WHOLE BLOOD TRANSFUSION WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY DUE TO THE BLOOD LOSS.

Additional Manufacturer Narrative

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE VENOUS LINE BROKE OFF FROM THE TWIST DURING THE MIDDLE OF PATIENT TREATMENT. ADDITIONAL INFORMATION WAS REQUESTED HOWEVER A RESPONSE WAS NOT RECEIVED. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS NOT PROVIDED. NO SERIOUS INJURY OR REQUIRED MEDICAL INTERVENTION WAS REPORTED. NO PARTS WERE REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

CLINICAL REVIEW: A TEMPORAL RELATIONSHIP EXISTS BETWEEN HD THERAPY UTILIZING COMBISET BLOODLINES AND THE ADVERSE EVENT OF BLOOD LOSS, RESULTING IN HOSPITALIZATION AND THE NEED FOR FLUID REPLENISHMENT. THE PATIENT¿S TOTAL BLOOD LOSS WAS APPROXIMATED AT 700 ML OR CONSIDERED 10% TO 15% OF BLOOD VOLUME FOR AN ADULT FEMALE PER ADVANCED TRAUMA LIFE SUPPORT (ATLS) STANDARDS. ADDITIONALLY, THERE WAS NO INDICATION OF RESULTING SERIOUS INJURY AS THE BLOOD LOSS WAS DETERMINED TO BE LESS THAN 30% OF SYSTEMIC VOLUME. IN THE ABSENCE OF A CONFIRMED SOURCE OF THE LUER-LOCK BREAKAGE OR PRODUCT EVALUATION OF THE BLOODLINES, A CAUSE CANNOT BE ESTABLISHED; HOWEVER, IT CAN BE CONFIRMED THE PATIENT¿S BLOOD LOSS WAS THE DIRECT RESULT FROM A PRODUCT DEFICIENCY. REGARDLESS, BLOOD LOSS DURING HD THERAPY IS A KNOWN AND AN ANTICIPATED COMPLICATION THAT VARIES IN SEVERITY AND CAUSALITY AS DETAILED IN THE COMBISET BLOODLINES INSTRUCTIONS FOR USE. BASED ON THE AVAILABLE INFORMATION, THE PROVIDED NARRATIVE AND PHOTOGRAPHIC EVIDENCE AFFIRMS THIS PATIENT¿S BLOOD LOSS WAS DUE TO A PRODUCT DEFICIENCY IN THE COMBISET BLOODLINES; HOWEVER, THERE IS NO OBJECTIVE EVIDENCE THAT DEMONSTRATES THE ROOT CAUSE OF THE BREAKAGE OF THE VENOUS LINE CONNECTION AS OF THIS REPORTING. THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MDR WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

Description of Event or Problem

THE FACILITY ADMINISTRATOR (FA) REPORTED TO FRESENIUS THAT A BLOOD LEAK OCCURRED DURING THE PATIENT'S HEMODIALYSIS (HD) TREATMENT. THE VENOUS LINE BROKE OFF FROM THE TWIST DURING THE MIDDLE OF PATIENT TREATMENT. ADDITIONAL INFORMATION WAS RECEIVED DURING FOLLOW-UP. THE REPORTED ISSUE WAS DISCOVERED UPON COMPLETION OF THE PATIENT'S THREE-HOUR TREATMENT. THE BLOOD LEAK WAS VISUALLY OBSERVED. NO ALARMS WERE RECEIVED ON THE 2008T MACHINE. THERE WERE NO CHANGES OR DISRUPTIONS IN PRESSURE THAT COULD HAVE CAUSED THE ISSUE AND/OR MAY HAVE CAUSED THE MACHINE TO ALARM. NO LOOSE CONNECTION, DEFECT, OR DAMAGE WAS NOTED TO THE BLOODLINES PRIOR TO THE EVENT. ADDITIONALLY NO ISSUES WERE ENCOUNTERED WHILE PRIMING THE SETUP FOR THIS TREATMENT. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 700 ML. THE PATIENT WAS SENT TO THE EMERGENCY DEPARTMENT AS A PRECAUTIONARY MEASURE. TESTING WAS CARRIED OUT UPON ADMISSION, PRESUMABLY TO ASCERTAIN ANY LEVEL OF ANEMIA OR ADVERSE EFFECTS ATTRIBUTED TO THE BLOOD LOSS. THE PATIENT WAS ADMITTED TO THE HOSPITAL ON THE SAME DAY AND PROVIDED A WHOLE BLOOD TRANSFUSION WHILE HOSPITALIZED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2025. THERE WAS NO INDICATION OF RESULTING PATIENT SERIOUS INJURY DUE TO THE BLOOD LOSS.