Sample evaluation findings: sample 1: -the plasma line was not properly sealed -no scrape marks were found on the rotor and inside the case -no leaks were found in the rotor membrane -there was a nonconcentric impression wear on the seal ring from the eyelet, indicating a misalignment of the rotor to the case/pivot -there were no defects with eyelet and pivot -the dental cast of rotor bearing cavity showed no deformation or defects -the ovality test was passed -the i.D.Of the case plasma port was concentric to the o.D.Sample 2: -the plasma line was not properly sealed -no scrape marks were found on the rotor and inside the case -no leaks were found in the rotor membrane -there were no defects with seal ring, eyelet and pivot -the dental cast of rotor bearing cavity showed no deformation or defects -the ovality test was passed -the i.D.Of the case plasma port was concentric to the o.D.Sample 3: -the plasma line was not properly sealed -no scrape marks were found on the rotor and inside the case -no leaks were found in the rotor membrane -there were no defects with seal ring, eyelet and pivot -the dental cast of rotor bearing cavity showed no deformation or defects -the ovality test was not passed -the i.D.Of the case plasma port was concentric to the o.D.Sample 4: -the plasma line was not properly sealed -no scrape marks were found on the rotor and inside the case -no leaks were found in the rotor membrane -there were no defects with seal ring, eyelet and pivot -the dental cast of rotor bearing cavity showed no deformation or defects -the ovality test was passed -the i.D.Of the case plasma port was concentric to the o.D.Sample 5: -the plasma line was not properly sealed -no scrape marks were found on the rotor and inside the case -no leaks were found in the rotor membrane -there was a nonconcentric impression wear on the seal ring from the eyelet, indicating a misalignment of the rotor to the case/pivot -there were no defects with eyelet and pivot -the dental cast of rotor bearing cavity showed no deformation or defects -the ovality test was passed -the i.D.Of the case plasma port was concentric to the o.D.Sample 6: -used parts of a kit contaminated with blood.-the separation device was not returned, investigation was not possible.Customer's complaint is confirmed.The batch record for product code 6r2262, lot fa23b21369 was reviewed.No exceptions were generated that could classify as a possible root cause of this defect.The finished good lot has passed all sampling acceptance criteria for all tests performed including in-process testing and product testing.Current controls: to assure integrity of the kit, the following controls are established at the disposable manufacturing site: -in process sampling quality inspection.-post sterilization sampling final inspection.-quality and manufacturing inspection.Track and trend: fresenius kabi received a total of 2 discolored urine incidents against product code 6r2262, lot fa23b21369.A monthly trend is performed to determine the need to initiate an investigation due to an increase in complaints or to determine if corrective actions are needed.An adverse trend was observed for this defect category.Capa 1700421 was issued to perform the applicable investigation and identify corrective actions.Root cause identified in capa 1700421: the primary root cause is the surface finish of the pin, which can create friction that stops the roller.The stopped roller pulls tubing, creating a kink.If the roller stoppage occurs on the blood pump and the kink occurs on return, hemolysis is not immediately detected, leading to discolored urine.Confounding factors include application of silicone lubricant, which increases the likelihood of roller stoppage and long/stretched/twisted tubing, which increases the likelihood of a kink.Corrective action: the following corrective actions were defined in capa 1700421: -improved detection of roller cages at risk of having a stuck roller -improvement of current roller pin surface finish -to instruct operators and service technicians not to use lubricants on the roller cages.
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