COMBISET ACCESS FLOW REVERSE CON TWISTER

Additional Manufacturer Narrative

PLANT INVESTIGATION: THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. AS THE COMPLAINT PRODUCT SAMPLE WAS DISINFECTED AND PREPARED FOR ANALYSIS, A LEAK WAS OBSERVED ON THE SEAL SIDE OF THE TWISTER. AFTER FURTHER INSPECTION, NO OTHER PROBLEMS WERE IDENTIFIED. DURING THE VISUAL INSPECTION A GAP WAS FOUND BETWEEN THE SEAL OF THE TWISTER. BOTH PARTS OF THE TWISTER WERE NOT ASSEMBLED CORRECTLY. AFTER FURTHER INSPECTION, NO ADDITIONAL ISSUES WERE IDENTIFIED IN THE REMAINING COMPONENTS OF THE SET. 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¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FORM THE TWISTER ONE HOUR AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE BLOODLINE. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S BLOOD WAS RETURNED FOLLOWING THE REPORTED EVENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

Additional Manufacturer Narrative

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¿S REGISTERED NURSE (RN) REPORTED THAT A FRESENIUS COMBISET BLOODLINE LEAKED FORM THE TWISTER ONE HOUR AFTER THE INITIATION OF A PATIENT¿S HEMODIALYSIS (HD) TREATMENT. THE MACHINE, A FRESENIUS 2008T MACHINE, DID NOT ALARM, BUT WAS NOT EXPECTED TO. A FRESENIUS DIALYZER WAS ALSO IN USE. THERE WERE NO ISSUES NOTED DURING PRIMING. THERE WAS NO DEFECT OR DAMAGE NOTED ON THE BLOODLINE. THERE WERE NO CHANGES IN PRESSURE OR BLOOD FLOW RATE DURING TREATMENT. THE PATIENT¿S BLOOD WAS RETURNED FOLLOWING THE REPORTED EVENT. THE PATIENT¿S ESTIMATED BLOOD LOSS (EBL) WAS APPROXIMATELY 20ML. THERE WAS NO PATIENT SERIOUS INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON THE SAME MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. THE COMPLAINT DEVICE WAS REPORTED TO BE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.