COMBISET ACCESS FLOW REVERSE CON TWISTER

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER REPORTED THAT A COMBISET ACCESS FLOW REVERSE CON TWISTER BLOOD LINE¿S PLASTIC TWIST CONNECTION FOR THE ACCESS FLOW BROKE AN HOUR INTO A PATIENT¿S HEMODIALYSIS TREATMENT AND CAUSED A BLOOD LEAK. THE LEAK WAS CONFIRMED TO BE EXTERNAL AND VISUALLY OBSERVED BY THE STAFF. THE CLINICAL MANAGER CONFIRMED THERE WERE NO ISSUES DURING PRIMING AND NO CHANGES IN PRESSURE THAT COULD ACCOUNT FOR THIS ISSUE. IT WAS STATED THERE WAS NO DAMAGE OR DEFECTS SEEN ON THE BLOODLINES. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. IT WAS CONFIRMED THAT THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE 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

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, THREE PHOTOGRAPHS OF THE COMBI SET WERE PROVIDED BY THE CUSTOMER. EVIDENCE OF A BLOOD LEAK WAS APPARENT IN THE PROVIDED PHOTOGRAPHS. ACCORDING TO THE PICTURES RECEIVED IT COULD BE OBSERVED THAT THE TOP PORT OF THE TWISTER WAS BROKEN FROM THE VENOUS LINE. 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. THE CAUSE OF THE BROKEN PORT COULD NOT BE ESTABLISHED DUE TO NO SAMPLE WAS AVAILABLE TO PERFORM A FURTHER INVESTIGATION. HOWEVER, THIS KIND OF DAMAGE COULD BE CAUSED DUE TO AN INCORRECT HANDLING OF THE PRODUCT EITHER DURING THE MANUFACTURING PROCESS OR TREATMENT SET UP. DURING THE MANUFACTURING PROCESS COULD BE DAMAGED DUE TO THE FOLLOWING CAUSES: INCORRECT ASSEMBLY TECHNIQUE/UNQUALIFIED OPERATOR. THE REPORTED EVENT WAS CONFIRMED BASED ON THE PROVIDED PHOTOGRAPHS.

Description of Event or Problem

A USER FACILITY CLINICAL MANAGER REPORTED THAT A COMBISET ACCESS FLOW REVERSE CON TWISTER BLOOD LINE¿S PLASTIC TWIST CONNECTION FOR THE ACCESS FLOW BROKE WHEN TWISTING AN HOUR INTO A PATIENT¿S HEMODIALYSIS TREATMENT AND CAUSED A BLOOD LEAK. THE LEAK WAS CONFIRMED TO BE EXTERNAL AND VISUALLY OBSERVED BY THE STAFF. THE CLINICAL MANAGER CONFIRMED THERE WERE NO ISSUES DURING PRIMING AND NO CHANGES IN PRESSURE THAT COULD ACCOUNT FOR THIS ISSUE. IT WAS STATED THERE WAS NO DAMAGE OR DEFECTS SEEN ON THE BLOODLINES. THE PATIENT'S ESTIMATED BLOOD LOSS (EBL) WAS LESS THAN 100 ML. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REQUIRED AS A RESULT OF THIS EVENT. THE PATIENT WAS RESTARTED ON A NEW MACHINE AND TREATMENT COMPLETED SUCCESSFULLY WITH NEW SUPPLIES. IT WAS CONFIRMED THAT THE COMPLAINT DEVICE WAS DISCARDED AND IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.