COMBISET BLOODLINE

Description of Event or Problem

A USER FACILITY CHARGE NURSE (CN) REPORTED A PATIENT EXPERIENCED BLOOD LOSS WHEN STARTING HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CN STATED SEVERAL MINUTES AFTER INITIATION OF TREATMENT, THE PATIENT CARE TECHNICIAN (PCT) CAME TO INVERT THE DIALYZER FROM THE BLUE TO THE RED SIDE UP AND STATED THE ARTERIAL SECTION OF THE COMBISET TUBING LINE DISLODGED FROM THE RED CONNECTION PIECE. THE MACHINE, A 2008T, ALARMED WITH AN ARTERIAL BLOOD LEAK ALERT AND THE PCT IMMEDIATELY CLAMPED OFF THE REMAINING TUBING LINE TO STOP THE BLOOD LEAK. PER CN IT WAS UNKNOWN WHAT CAUSED THE TUBING LINE TO DISCONNECT. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS 180NRE DIALYZER WERE BEING USED DURING THE INCIDENT. BLOOD TEST STRIPS WERE NOT REQUIRED OR USED. THE PATIENT'S BLOOD WAS NOT RETURNED AND THE ESTIMATED BLOOD LOSS (EBL) WAS 300ML. IMMEDIATELY FOLLOWING THE EVENT, THE TREATMENT WAS HALTED AND THE PATIENT WAS RE-SETUP WITH A NEW DIALYZER AND BLOODLINES, AND COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBISET WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, A PHOTO OF THE ALLEGED WAS RECEIVED FROM THE CUSTOMER AND COULD BE CONFIRMED THAT THE MAIN LINE IS SEPARATED FROM THE RED "T" CONNECTOR. THE REPORTED EVENT WAS CONFIRMED IN ACCORDANCE WITH THE PICTURE RECEIVED. 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. A PRODUCT HISTORY REVIEW DID NOT REVEAL A PROBABLE CAUSE FOR THE CUSTOMER COMPLAINT. THE EVENT WAS CONFIRMED.

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 CHARGE NURSE (CN) REPORTED A PATIENT EXPERIENCED BLOOD LOSS WHEN STARTING HEMODIALYSIS (HD) TREATMENT. UPON FOLLOW-UP, THE CN STATED SEVERAL MINUTES AFTER INITIATION OF TREATMENT, THE PATIENT CARE TECHNICIAN (PCT) CAME TO INVERT THE DIALYZER FROM THE BLUE TO THE RED SIDE UP AND STATED THE ARTERIAL SECTION OF THE COMBISET TUBING LINE DISLODGED FROM THE RED CONNECTION PIECE. THE MACHINE, A 2008T, ALARMED WITH AN ARTERIAL BLOOD LEAK ALERT AND THE PCT IMMEDIATELY CLAMPED OFF THE REMAINING TUBING LINE TO STOP THE BLOOD LEAK. PER CN IT WAS UNKNOWN WHAT CAUSED THE TUBING LINE TO DISCONNECT. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS 180NRE DIALYZER WERE BEING USED DURING THE INCIDENT. BLOOD TEST STRIPS WERE NOT REQUIRED OR USED. THE PATIENT'S BLOOD WAS NOT RETURNED AND THE ESTIMATED BLOOD LOSS (EBL) WAS 300ML. IMMEDIATELY FOLLOWING THE EVENT, THE TREATMENT WAS HALTED AND THE PATIENT WAS RE-SETUP WITH A NEW DIALYZER AND BLOODLINES AND COMPLETED THEIR TREATMENT ON THE SAME MACHINE. THE CN CONFIRMED THERE WAS NO PATIENT INJURY, NO ADVERSE EFFECTS WERE EXPERIENCED, AND NO MEDICAL INTERVENTION WAS REQUIRED AS A RESULT OF THE REPORTED EVENT. THE COMBISET WAS DISCARDED AND WAS NO LONGER AVAILABLE TO BE RETURNED FOR EVALUATION.