CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. 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. AS A PHYSICAL EVALUATION COULD NOT BE PERFORMED, A DEFINITIVE CONCLUSION REGARDING THE REPORTED INCIDENT COULD NOT BE REACHED AND A CAUSE COULD NOT BE CONFIRMED.

Description of Event or Problem

A USER FACILITY FACILITY ADMINISTRATOR (FA) REPORTED A CRIT LINE SEPARATION BETWEEN THE DIALYZER AND TWISTER LINE, CAUSING THE PATIENT TO LOSE BLOOD. THE FA REPORTED THE CRIT-LINE DID NOT THREAD EASILY ONTO TWISTER LINES, CAUSING A MALFUNCTION. THE MACHINE ITSELF NEVER ALARMED. UPON FOLLOW-UP, THE FA STATED STAFF OUND THE CRIT LINE UNTWISTED AND DETACHED FROM BETWEEN THE ARTERIAL END OF THE 180NRE DIALYZER (LOT NUMBER UNKNOWN) AND THE BLOOD CHAMBER, AND CAUSED A BLOOD LEAK TO OCCUR. THE FA BELIEVED THE CRIT-LINE DID NOT THREAD EASILY ONTO TWISTER LINES AND SOMEHOW UNTWISTED DURING TREATMENT. THE FA STATED THE EVENT OCCURRED AN HOUR AND A HALF AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE HEMODIALYSIS (HD) MACHINE, A 2008T, MACHINE DID NOT ALARM WITH ANY BLOOD LEAK ALERT. THE PATIENT WAS DIALYZING USING FRESENIUS BLOODLINES. IMMEDIATELY FOLLOWING THE EVENT, TREATMENT WAS HALTED AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 300 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AS A PRECAUTION AND FOR OBSERVATION. THE FA STATED NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT REMAINED STABLE. THE PATIENT'S HEMOGLOBIN (HB) COUNT WAS 11.4 G/DL PRE-TREATMENT AND 8.3 G/DL POST-TREATMENT. THE MACHINE HAS REMAINED IN SERVICE. THE FA STATED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY AND AS OF (B)(6) 2026 THE PATIENT'S HB COUNT IS 11.9 G/DL. THE BLOOD CHAMBER WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.

Additional Manufacturer Narrative

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

Description of Event or Problem

A USER FACILITY FACILITY ADMINISTRATOR (FA) REPORTED A CRIT LINE SEPARATION BETWEEN THE DIALYZER AND TWISTER LINE, CAUSING THE PATIENT TO LOSE BLOOD. THE FA REPORTED THE CRIT-LINE DID NOT THREAD EASILY ONTO TWISTER LINES, CAUSING A MALFUNCTION. THE MACHINE ITSELF NEVER ALARMED. UPON FOLLOW-UP, THE FA STATED STAFF OUND THE CRIT LINE UNTWISTED AND DETACHED FROM BETWEEN THE ARTERIAL END OF THE 180NRE DIALYZER (LOT NUMBER UNKNOWN) AND THE BLOOD CHAMBER, AND CAUSED A BLOOD LEAK TO OCCUR. THE FA BELIEVED THE CRIT-LINE DID NOT THREAD EASILY ONTO TWISTER LINES AND SOMEHOW UNTWISTED DURING TREATMENT. THE FA STATED THE EVENT OCCURRED AN HOUR AND A HALF AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE HEMODIALYSIS (HD) MACHINE, A 2008T, MACHINE DID NOT ALARM WITH ANY BLOOD LEAK ALERT. THE PATIENT WAS DIALYZING USING FRESENIUS BLOODLINES. IMMEDIATELY FOLLOWING THE EVENT, TREATMENT WAS HALTED AND THE PATIENT'S BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 300 ML. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM (ER) AS A PRECAUTION AND FOR OBSERVATION. THE FA STATED NO MEDICAL INTERVENTION WAS REQUIRED AND THE PATIENT REMAINED STABLE. THE PATIENT'S HEMOGLOBIN (HB) COUNT WAS 11.4 G/DL PRE-TREATMENT AND 8.3 G/DL POST-TREATMENT. THE MACHINE HAS REMAINED IN SERVICE. THE FA STATED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE PATIENT WAS RELEASED FROM THE HOSPITAL THE SAME DAY AND AS OF (B)(6) 2026 THE PATIENT'S HB COUNT IS 11.9 G/DL. THE BLOOD CHAMBER WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.