COMBISET BLOODLINE

Additional Manufacturer Narrative

PLANT INVESTIGATION: AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER, A PHYSICAL EVALUATION COULD NOT BE PERFORMED. HOWEVER, PICTURES WERE RECEIVED FROM THE CLINIC. IT COULD BE CONFIRMED THAT THE TOP CAP IS DETACHED FROM THE VENOUS CHAMBER. ACCORDING TO THE PICTURES, NO SOLVENT PRESENCE COULD BE OBSERVED IN THE CHAMBER OR THE TOP CAP. THE REPORTED EVENT WAS CONFIRMED IN ACCORDANCE WITH THE PICTURE RECEIVED. POTENTIAL ROOT CAUSES. BASED ON PF-BL-0026 REV. AB, THE OBSERVED DAMAGE MAY BE ATTRIBUTED TO IMPROPER ASSEMBLY DURING THE MANUFACTURING PROCESS. POSSIBLE CONTRIBUTING FACTORS INCLUDE: ¿ ASSEMBLED WITH LOW AIR PRESSURE BECAUSE OF PRESSURE DIGITAL SWITCH DAMAGED. ¿DAMAGED ASSEMBLY CYLINDER. ¿DISTORTED COMPONENTS. ¿LOW LEVEL OF SOLVENT BECAUSE OF DAMAGED PRESENCE SENSOR OF SOLVENT OR SOLVENT PUMP DAMAGED. ¿MISADJUSTED CYLINDER STROKE IN WET STATION. ¿MISALIGNED BASE OF CHAMBERS. ¿MISALIGNED PLATE OF TOP CAPS. ¿MISALIGNED TOP CAP NEST. ¿OCCLUDED SOLVENT LINE. ¿OPERATOR DOES NOT FOLLOW THE INDICATIONS FROM THE APPLICABLE MODULE. ¿STATION CYLINDER DOES NOT COMPLETE TO DOWN. 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.

Description of Event or Problem

A USER FACILITY PATIENT CARE TECHNICIAN (PCT) REPORTED A BLOOD LEAK DETECTOR PUMPING BLOOD OUT OF TOP OF CHAMBER THAT CAME OFF. PHOTOS WERE PROVIDED FOR THE INVESTIGATION. UPON FOLLOW-UP, THE PCT STATED THE TOP OF THE BLOOD LEAK DETECTOR CHAMBER CAME OFF AND A BLOOD LEAK OCCURRED DURING RINSEBACK OF TREATMENT. THE MACHINE, A 2008T, ALARMED WITH AN ARTERIAL BLOOD LEAK ALERT. PER PCT THE CAP CAME OFF AND BLOOD LEAKED OUT. PER PCT IT WAS UNKNOWN WHAT CAUSED THE CAP TO COME OFF AND FOR THE LEAK TO OCCUR. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS 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 100ML. 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 PCT 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. PHOTOS WERE PROVIDED FOR THE INVESTIGATION.

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 PATIENT CARE TECHNICIAN (PCT) REPORTED A BLOOD LEAK DETECTOR PUMPING BLOOD OUT OF TOP OF CHAMBER THAT CAME OFF. PHOTOS WERE PROVIDED FOR THE INVESTIGATION. UPON FOLLOW-UP, THE PCT STATED THE TOP OF THE BLOOD LEAK DETECTOR CHAMBER CAME OFF AND A BLOOD LEAK OCCURRED DURING RINSEBACK OF TREATMENT. THE MACHINE, A 2008T, ALARMED WITH AN ARTERIAL BLOOD LEAK ALERT. PER PCT THE CAP CAME OFF AND BLOOD LEAKED OUT. PER PCT IT WAS UNKNOWN WHAT CAUSED THE CAP TO COME OFF AND FOR THE LEAK TO OCCUR. A FRESENIUS 2008T HEMODIALYSIS MACHINE AND FRESENIUS 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 100ML. 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 PCT 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. PHOTOS WERE PROVIDED FOR THE INVESTIGATION.