CLIC BLOOD CHAMBER

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE CM DURING FOLLOW-UP. THE BLOOD LEAK OCCURRED APPROXIMATELY TWO HOURS INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT'S TREATMENT WAS SETUP WITH A FRESENIUS 2008T MACHINE AND A FRESENIUS DIALYZER. THE BLOOD LEAK WAS VISUALLY OBSERVED BY A MEMBER OF THE DIALYSIS UNIT. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE CLIC BLOOD CHAMBER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. A PROPHYLACTIC WAS ADMINISTERED TO THE PATIENT (VANCOMYCIN, 500 MG, INTRAVENOUSLY (IV), ONE TIME). TREATMENT WAS RESTARTED AND COMPLETED SUCCESSFULLY ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT SAMPLE WAS DISCARDED AND IS UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

Additional Manufacturer Narrative

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

Additional Manufacturer Narrative

CORRECTION: H6 (HEALTH EFFECT CLINICAL CODE) PLANT INVESTIGATION: THE MANUFACTURER DID NOT RECEIVE THE COMPLAINT PRODUCT SAMPLE FOR EVALUATION. HOWEVER, A PHOTOGRAPH OF THE ALLEGED MALFUNCTION WAS RECEIVED. ACCORDING WITH THE PHOTOGRAPH A SEPARATION COULD BE OBSERVED BETWEEN THE CLIC BODY AND DIN CONNECTOR. THE ALLEGED FAILURE MODE WAS CONFIRMED WITH THE PHOTOGAPH RECEIVED. A BATCH RECORDS REVIEW WAS CONDUCTED BY THE MANUFACTURER FOR THE REPORTED LOT. ONE NONCONFORMANCE WAS FOUND THAT IS RELATED TO THE FAILURE MODE ALLEGED IN THE COMPLAINT. THE NONCONFORMANCE ADDRESSES A SEPARATION FOUND BETWEEN THE CLIC BODY AND DIN CONNECTOR WHICH ALSO CONFIRMS THE REPORTED ISSUE. THIS KIND OF FAILURE MODE COULD BE CAUSED FROM OPERATOR ERROR, A MALFUNCTIONING DISPENSER, LACK OF SOLVENT IN DISPENSER, OBSTRUCTION IN SOLVENT CIRCUIT, FLOW REGULATOR OBSTRUCTED OR CLOSED, SOLVENT LEVEL, REGULATION OF SOLVENT DISPENSED QUANTITY, WETTING MECHANIC DOES NOT WORK, COMPONENT TEMPERATURE, OR A GRIPPER SYSTEM MALFUNCTION. 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.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED TO FRESENIUS CUSTOMER SERVICE THAT THE CRIT-LINE CLIP (CLIC) BLOOD CHAMBER LEAKED DURING A PATIENT'S HEMODIALYSIS (HD) TREATMENT. ADDITIONAL INFORMATION WAS PROVIDED BY THE CM DURING FOLLOW-UP. THE BLOOD LEAK OCCURRED APPROXIMATELY TWO HOURS INTO THE PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE PATIENT'S TREATMENT WAS SETUP WITH A FRESENIUS 2008T MACHINE AND A FRESENIUS DIALYZER. THE BLOOD LEAK WAS VISUALLY OBSERVED BY A MEMBER OF THE DIALYSIS UNIT. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE CLIC BLOOD CHAMBER. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 300 ML. THE PATIENT DID NOT EXPERIENCE A SERIOUS INJURY OR REQUIRE MEDICAL INTERVENTION AS A RESULT OF THE REPORTED ISSUE. A PROPHYLACTIC WAS ADMINISTERED TO THE PATIENT (VANCOMYCIN, 500 MG, INTRAVENOUSLY (IV), ONE TIME). TREATMENT WAS RESTARTED AND COMPLETED SUCCESSFULLY ON THE SAME MACHINE WITH NEW SUPPLIES. THE COMPLAINT SAMPLE WAS DISCARDED AND IS UNAVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.