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 REGISTERED NURSE (RN) REPORTED A BLOOD LEAKAGE FROM A CRIT-LINE BLOOD CHAMBER THAT OCCURRED DURING A PATIENT TREATMENT. THE RN REPORTED THE CRIT-LINE BLOOD CHAMBER EXHIBITED A BLOOD LEAKAGE FROM THE SEAM WHERE THE CRIT-LINE CLIC CONNECTS. AS A RESULT, THE TREATMENT WAS HALTED, THE BLOOD WAS RETURNED TO THE PATIENT, AND AN ENTIRELY NEW SETUP WAS IMPLEMENTED, ALLOWING THE TREATMENT TO CONTINUE WITHOUT ANY FURTHER INCIDENTS. THE COMPROMISED BLOOD CHAMBER WAS NOT SAVED AND WAS DISPOSED OF. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED ON (B)(6) 2025 IMMEDIATELY AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT, A BLOOD LEAK WAS OBSERVED FROM THE SEAM WHERE THE CRIT-LINE CLIC CONNECTS. TREATMENT WAS PAUSED AND THE PATIENT¿S BLOOD WAS SUCCESSFULLY RETURNED. PER CM THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS MINIMAL AND DID NOT PROVIDE A QUANTITATIVE VOLUME. THE CM NOTED THAT THE PATIENT REMAINED ASYMPTOMATIC AND CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE. THE MACHINE, A 2008T, WAS NOT EXPECTED TO AND DID NOT ALARM. THE PATIENT WAS UTILIZING FRESENIUS BLOODLINES. NO DAMAGE WAS NOTED ON THE CRIT-LINE BLOOD CHAMBER PRIOR TO TREATMENT. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED TREATMENT WITHOUT FURTHER ISSUE. THE MACHINE HAS REMAINED IN SERVICE. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE SAMPLE 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 REGISTERED NURSE (RN) REPORTED A BLOOD LEAKAGE FROM A CRIT-LINE BLOOD CHAMBER THAT OCCURRED DURING A PATIENT TREATMENT. THE RN REPORTED THE CRIT-LINE BLOOD CHAMBER EXHIBITED A BLOOD LEAKAGE FROM THE SEAM WHERE THE CRIT-LINE CLIC CONNECTS. AS A RESULT, THE TREATMENT WAS HALTED, THE BLOOD WAS RETURNED TO THE PATIENT, AND AN ENTIRELY NEW SETUP WAS IMPLEMENTED, ALLOWING THE TREATMENT TO CONTINUE WITHOUT ANY FURTHER INCIDENTS. THE COMPROMISED BLOOD CHAMBER WAS NOT SAVED AND WAS DISPOSED OF. UPON FOLLOW-UP, THE CLINIC MANAGER (CM) STATED ON (B)(6) 2025 IMMEDIATELY AFTER INITIATION OF THE PATIENT'S HEMODIALYSIS (HD) TREATMENT, A BLOOD LEAK WAS OBSERVED FROM THE SEAM WHERE THE CRIT-LINE CLIC CONNECTS. TREATMENT WAS PAUSED AND THE PATIENT¿S BLOOD WAS SUCCESSFULLY RETURNED. PER CM THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS MINIMAL AND DID NOT PROVIDE A QUANTITATIVE VOLUME. THE CM NOTED THAT THE PATIENT REMAINED ASYMPTOMATIC AND CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE. THE MACHINE, A 2008T, WAS NOT EXPECTED TO AND DID NOT ALARM. THE PATIENT WAS UTILIZING FRESENIUS BLOODLINES. NO DAMAGE WAS NOTED ON THE CRIT-LINE BLOOD CHAMBER PRIOR TO TREATMENT. IMMEDIATELY FOLLOWING THE EVENT, THE PATIENT WAS RE-SETUP WITH NEW SUPPLIES ON THE SAME MACHINE AND COMPLETED TREATMENT WITHOUT FURTHER ISSUE. THE MACHINE HAS REMAINED IN SERVICE. THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE SAMPLE WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.