5008X HD/HDF - STANDARD BLOOD TUBING SET

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3 PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. THE SAMPLE WAS RECEIVED IN PACKAGING DIFFERENT FROM THE STANDARD CONFIGURATION. THE SAMPLE WAS DISINFECTED IN ACCORDANCE WITH PROCEDURE. DURING DISINFECTION AND PREPARATION FOR ANALYSIS, IT WAS OBSERVED THAT THE MAIN ARTERIAL LINE CONNECTED TO THE ALPHA CLIP WAS DETACHED. NO ADDITIONAL ABNORMALITIES WERE IDENTIFIED UPON FURTHER INSPECTION. A VISUAL INSPECTION WAS PERFORMED. UNDER MICROSCOPIC EXAMINATION, SOLVENT RESIDUE WAS DETECTED AT BOTH THE END OF THE TUBE AND WITHIN THE PORT OF THE ALPHA CLIP. NO OTHER ISSUES WERE FOUND IN THE REMAINING COMPONENTS OF THE SET. THE REPORTED ISSUE WAS CONFIRMED DURING THE EVALUATION. 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. 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. UPON COMPLETION OF THE EVALUATION, THE REPORTED EVENT WAS CONFIRMED.

Description of Event or Problem

A USER FACILITY CLINIC MANAGER (CM) REPORTED APPROXIMATELY TWO HOURS INTO HEMODIALYSIS (HD) TREATMENT, A CLINICIAN NOTICED BLOOD LEAKING DOWN FROM THE ALPHA CLIP. UPON FURTHER INSPECTION, BLOOD WAS IN FACT LEAKING FROM CONNECTION AT THE CLIP. THE PATIENT WAS REINFUSED AS THERE WAS NO AIR IN THE LINES. WHEN LINES WERE REMOVED FROM MACHINE, THEY COMPLETELY DISCONNECTED AT THE ALPHA CLIP. LINES WERE SAVED AND SENT OUT FOR EVALUATION. UPON FOLLOW-UP, THE CM STATED A PATIENT WAS TWO HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 5008X MACHINE WHEN STAFF NOTICED BLOOD LEAKING DOWN FROM THE ALPHA CLIP. TREATMENT WAS IMMEDIATELY HALTED. A FRESENIUS FX CORAL 60 DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS SUCCESSFULLY REINFUSED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 30 CC. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT WAS RESTARTED ON A DIFFERENT MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR 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 APPROXIMATELY TWO HOURS INTO HEMODIALYSIS (HD) TREATMENT, A CLINICIAN NOTICED BLOOD LEAKING DOWN FROM THE ALPHA CLIP. UPON FURTHER INSPECTION, BLOOD WAS IN FACT LEAKING FROM CONNECTION AT THE CLIP. THE PATIENT WAS REINFUSED AS THERE WAS NO AIR IN THE LINES. WHEN LINES WERE REMOVED FROM MACHINE, THEY COMPLETELY DISCONNECTED AT THE ALPHA CLIP. LINES WERE SAVED AND SENT OUT FOR EVALUATION. UPON FOLLOW-UP, THE CM STATED A PATIENT WAS TWO HOURS INTO DIALYSIS TREATMENT ON A FRESENIUS 5008X MACHINE WHEN STAFF NOTICED BLOOD LEAKING DOWN FROM THE ALPHA CLIP. TREATMENT WAS IMMEDIATELY HALTED. A FRESENIUS FX CORAL 60 DIALYZER WAS USED FOR TREATMENT AND THE PATIENT'S BLOOD WAS SUCCESSFULLY REINFUSED. THE CM STATED THAT THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS 30 CC. THE CM CONFIRMED THERE WAS NO PATIENT INJURY, ADVERSE EVENTS, OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THE REPORTED EVENT. THE MACHINE WAS NOT REMOVED FROM THE FLOOR AND REMAINED IN SERVICE. FOLLOWING THE EVENT, THE CM STATED THE PATIENT WAS RESTARTED ON A DIFFERENT MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH A NEW DIALYZER AND TUBING LINES WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.