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Investigation: the customer used a blood warmer and volume configured for 42 ml.Blood prime blood hct was 31.4 %.Post product hct was 1%.The customer reported they operated in caution status because at the beginning, they returned to the patient what was in the collect line because they were not ready to collect yet.The run data file (rdf) was analyzed for this event.Signals in the procedure along with the customer description indicate that the likely cause for the low post patient hematocrit was caused by the way in which custom blood prime was performed and the custom blood prime hematocrit used.After the operator entered the patient data, the system recommended that the operator perform custom prime and calculated that the patient volumes in tubing set would be 38% of the patients tbv and 60% of the patient¿s rbcs if custom prime was not performed.The operator performed custom prime, but according to the dlog, the way custom prime was performed was the operator diluted the custom prime fluid to a 31% hematocrit.This is not recommended as it limits the number of rbcs that are remaining in the set after custom prime is completed.The custom prime displaced the saline into the waste bag, but unfortunately the rbcs in the set were limited since the rbc fluid was diluted to a 31% hct.It is not recommended to use an rbc unit that is diluted with saline or plasma to decrease the hct of the custom prime fluid.This is because not enough rbcs will be delivered to the patient.In pediatric patients with low tbvs, the custom prime unit helps build up the rbc in the channel to minimize the extracorporeal rbc volume needed from the patient.The custom prime unit also helps to build the rbc layer in the channel for a more efficient establishment of the interface.At least 300 ml of rbc (undiluted) for custom prime should be processed to ensure the set has been adequately primed with rbc.This will allow approximately 95% of the saline in the tubing set to be removed.If a blood warmer is used on the return line, the additional volume of the blood warmer should also be added to the volume processed to ensure the tubing is completely primed with rbc.Custom prime rbc units should not be diluted to ensure patient safety and to help maximize efficiency of the procedure.Investigation is in process.A follow-up report will be provided.
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The customer reported that during a continuous mononuclear cell (cmnc) collection procedure on a pediatric patient with meduloblastoma, the patient's hematocrit dropped after doing blood prime.The customer reported inlet and return pressure alarms and had problems maintaining a good collect preference color because of the lines twisting around from the patient access.Prior to the procedure, the patient's hematocrit was 24.Post hematocrit of patient was 18.The physician ordered the patient admitted to the unit and transfused one unit of blood.The patient is reported as stable.Per the customer, during the procedure, calcium gluconate 0.45mg/kg/min 50mg/ml normal saline- were administered via stopcock to the return line.The disposable set is not available for return because it was discarded by the customer.
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This report is being filed to provide additional infomration in h.6 and h.10.Investigation: per follow-up with the customer, the calcium is diluted 1:1 with normal saline, starts as 100mg/ml, then diluted to 50mg/ml.Patient received 1280mg calcium gluconate total.Total fluid volume (half med/half ns since diluted 1:1) was 25.6mls.The customer reported they are experienced with performing primes and have changed their practice to no longer dilute prbc unit used for prime.In this case the patient started with low hct, between the diluted unit, blood sampling and hemodilution from positive fluid balance the hct dropped.Per the customer, the md should have ordered a partial rinseback.It was reported that they re-educated the dr's about ordering paritial rinseback on pts.With low pre hct.A lot query search was performed for lot 2004133130 and no similar reported occurrences were received against this lot to date.In procedures that use the idl channel, such as the cmnc procedure, the centrifuge does not spin during custom prime, and the volume and rbc content of the extracorporeal circuit at the end of custom prime is less than it will be after the procedure is initiated.This is due mainly to the expansion of the channel volume during centrifugation.The spectra optia operator¿s manual recommends using 300ml of priming blood to do a custom prime, or 340 ml if a blood warmer is used, as in this case.The volume of priming blood in the channel at the completion of custom prime with a blood warmer in place is about 230ml and the rbc volume when 350ml of priming blood is used is as follows: total extracorporeal rbc volume post prime = 230ml x 0.31 = 71.3ml rbc volume in channel post custom prime = 95ml x 0.31 = 29.5ml rbc volume in non-channel part of the tubing set post custom prime = 135ml x 0.31 = 41.9ml during custom prime the cassette volume for idl procedures includes 28 ml more fluid in the return reservoir than is present during the procedure, as a mitigation for channel expansion during the procedure.When the run begins the extra 28ml in the reservoir is infused into the patient at the same time as blood is being removed by the inlet pump.Inlet flow rate = 896/72 = 12.44 ml/min rpm = sqrt(12.44 x 33413) = 645 channel volume during run = 144ml + 0.033 x (645-500) = 148.8ml channel rbc volume during run = 148.8ml x 0.49 = 72.9ml during the procedure after volume stabilization the volume of blood in the non-channel part of the set will contain 107ml (135 ¿ 28) and the hematocrit is the same as the patient.Non-channel rbc volume = 107ml x 0.22 (patient hct during run) = 23.5ml patient hct during run = ((896ml x 0.24) + 71.3ml - 72.9ml))/ 896ml + 230ml - 148.8ml = 0.22 patient's rbc loss during run = 73ml + (67 ml x 0.22) - 71.3 = 16.44ml the customer provided the patient's complete blood count from nov 3 through nov 6, including a pre count and three post counts after the procedure.Date/time hematocrit (%) 11/3/50 (0425) 26 11/5/20 (1138) 25 11/6/20 (0816) 24 (pre) 11/6/20 (1333) 19 (post) 11/6/20 (1420) 18 11/6/20 (1854) 19 the patient's pre hct was 24% and post hct was 18%, representing a relative decrease of 25%.The model confirmed that additional 16.4ml of rbcs from the patient was required for interface setup after the centrifugation began due to channel expansion.However, the calculations indicated that the decrease in the patient's hematocrit should not have dropped beyond 22%.The final fluid balance was 113% and the patient received additional 25.6 ml calcium gluconate during the course of the procedure.Patient's tbv (post) = 896 ml x 1.13 = 1012 ml total rbc in collect bag (1 % hct) = 86 ml x 0.01 = 0.86 ml total patient's rbc (post) = (896 ml x 0.24) - 16.4 ml - 0.86 ml = 197.8 ml estimated patient's hct = 197.8 ml / 1012 ml x 100% = 19.5 % the patient's post hematocrit (19.5 %), after taking into consideration of the additional hypervolemic fluid balance and crystalloid solution associated with calcium gluconate, is close to the value calculated using the rbc loss model.Root cause: based on calculations of the volume of rbcs removed from the patient due to channel expansion post custom prime, the acute rbc loss was partly due to the use of low hematocrit blood prime.Correction: the offer of custom prime retraining was declined by the customer who confirmed that they no longer dilute packed red blood cell unit used for priming.Field action 38 was communicated shortly after this incident, in november 2020: 1.To inform customers performing a custom prime using red blood cells of the importance of ensuring that the custom prime unit contains enough red blood cells (rbc) or rbc volume (rcv) to adequately fill the extracorporeal circuit of the tubing set.An insufficient rcv may lead to an unintended decrease in patient hematocrit (hct).This issue may occur due to the use of low-volume and/or diluted custom prime rbc units.2.To provide additional information to mitigate the risk of using diluted and/or low-volume rbc custom prime units.Supplemental training, specific to performing a custom prime, is currently available in elearning format in english at www.Terumobct.Com/elearning titled "spectra optia custom prime elearning course".Corrective action: an existing internal capa was determined to be applicable to this event.The capa was initiated to investigate report of rbc depletion in a small pediatric patient due to inadequate custom prime and inappropriate operator entries during a spectra optia cmnc procedure.
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