CLIC BLOOD CHAMBER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3. PLANT INVESTIGATION: THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE COMPLAINT PRODUCT SAMPLE WAS DISINFECTED, AS THE COMPLAINT PRODUCT SAMPLE WAS BEING DISINFECTED AND PREPARED FOR ANALYSIS, IT WAS NOT FOUND A LEAK IN THE CLIC BLOOD CHAMBER. THE SAMPLE WAS TESTED UNDER WATER AT A PRESSURE OF 15 PSI, DURING THE TEST AN AIR LEAK COULD BE DETECTED BETWEEN THE UNION OF THE CLEAR BODY AND THE LENSES. DURING THE VISUAL INSPECTION WITH THE MICROSCOPE, IT WAS FOUND THAT THE LEAK WAS CAUSED DUE TO A BAD WELDING BETWEEN THE UNION OF THE CLEAR BODY AND THE LENSES AND THERE WAS A DAMAGE. ADDITIONAL, PICTURES WERE RECEIVED FROM THE CUSTOMER AND COULD BE CONFIRMED A LEAK FORM THE UNION OF THE CLEAR BODY AND THE LENSES. THIS KIND OF DAMAGED COULD BE CAUSED DUE TO AN INCORRECT ASSEMBLY DURING THE MANUFACTURING PROCESS. INCORRECT PARAMETERS, DUKANE SYSTEM MALFUNCTIONING, SENSOR MALFUNCTIONING, THE MECHANISM TO POSITIONATE LENS IS MALFUNCTIONING, SENSOR OF EQUIPMENT TO DETECT THE PIN IS MALFUNCTIONING, MISALIGNED MAIN TABLE, AND SUCTION SYSTEM MALFUNCTIONING. DURING THE DHR (DEVICE HISTORY RECORD) REVIEW THE LOT INVOLVED DOES NOT SHOW ANY NON-CONFORMANCES, DEVIATIONS OR ASSOCIATED REWORK RELATED TO THE ALLEGED COMPLAINT DESCRIPTION. A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND VERIFIED THAT THE RESULTS OF THE IN-PROGRESS AND FINAL QUALITY CONTROL (QC) TESTING MET ALL REQUIREMENTS. UPON COMPLETION OF THE EVALUATION, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED A SMALL CRACK ON THE SIDE OF A CLIC BLOOD CHAMBER THAT WAS CAUSING A SMALL LEAK THAT WAS NOT DETECTED UNTIL THE PATIENT WAS HOOKED UP AND BLOOD WAS MOVING THROUGH THE CIRCUIT. THE CM REPORTED THERE WAS A VERY SMALL CRACK THAT WAS HARD TO VISUALIZE AT FIRST. BLOOD WAS NOT RETURNED. UPON FOLLOW-UP, THE CM CONFIRMED THE REPORTED EVENT AND STATED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE B.BRAUN HEMODIALYSIS MACHINE DID NOT ALARM WITH ANY BLOOD LEAK ALERT. THE BLOOD LEAK WAS VISUALLY OBSERVED FROM A SMALL CRACK ALONG THE SIDE OF THE BLOOD CHAMBER. THE PATIENT WAS DIALYZING USING A FRESENIUS DIALYZER AND B.BRAUN BLOODLINES. THE PATIENT'S BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 10 ML. 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 BLOOD CHAMBER WAS 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 CLINIC MANAGER (CM) REPORTED A SMALL CRACK ON THE SIDE OF A CLIC BLOOD CHAMBER THAT WAS CAUSING A SMALL LEAK THAT WAS NOT DETECTED UNTIL THE PATIENT WAS HOOKED UP AND BLOOD WAS MOVING THROUGH THE CIRCUIT. THE CM REPORTED THERE WAS A VERY SMALL CRACK THAT WAS HARD TO VISUALIZE AT FIRST. BLOOD WAS NOT RETURNED. UPON FOLLOW-UP, THE CM CONFIRMED THE REPORTED EVENT AND STATED AN INTERNAL DIALYZER BLOOD LEAK OCCURRED IMMEDIATELY AFTER INITIATION OF HEMODIALYSIS (HD) TREATMENT. THE B.BRAUN HEMODIALYSIS MACHINE DID NOT ALARM WITH ANY BLOOD LEAK ALERT. THE BLOOD LEAK WAS VISUALLY OBSERVED FROM A SMALL CRACK ALONG THE SIDE OF THE BLOOD CHAMBER. THE PATIENT WAS DIALYZING USING A FRESENIUS DIALYZER AND B.BRAUN BLOODLINES. THE PATIENT'S BLOOD WAS NOT RETURNED. THE ESTIMATED BLOOD LOSS WAS APPROXIMATELY 10 ML. 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 BLOOD CHAMBER WAS AVAILABLE TO BE RETURNED FOR MANUFACTURER EVALUATION.