| Model Number 12320 |
| Device Problems
Inaccurate Flow Rate (1249); Use of Device Problem (1670)
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| Patient Problem
Hemoconcentration (1288)
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| Event Date 09/16/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation: per the customer, the inlet flow rate was approximately 8 mls/min during procedure, ratio 12, acir between 0.6 - 0.7ml/min/ltbv, ca++ gluconate infusing 2.1ml/hour via syringe pump (dose ordered 12mg/kg/hr).This customer reported that they perform cmnc procedures on adults regularly, therefore, were surprised when they did not receive the interface is taking too long to establish alarm.Terumo bct clinical support explained to customer that most likely the issue was the low inlet flow rate and the fact that optia was still able to make changes to the plasma pump.Due to the low inlet flow rate, it takes the interface alarm longer to occur in small tbv patients.(the customer also did not receive the inlet flow can cause platelet depletion warning since that does not occur during establishing interface but only during run).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 aborted procedure was due to a low interface throughout 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 54% of the patients tbv and 75% of the patient¿s rbcs if custom prime was not performed.The operator performed custom prime, but according to the rdf, the way custom prime was performed was the operator diluted the custom prime fluid to the patient¿s 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 the patients 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.The procedure had issues establishing an interface because there were not enough rbcs in the custom prime unit.Therefore, additional rbcs will need to be removed from the patient, which in turn will reduce the patients hct.Images and signals from the dlog confirmed this to be the case.Note: when performing a custom prime, blood warmer tubing needs to also be considered.In this procedure the blood warmer tubing was 48ml.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that while performing a continuous mononuclear cell (cmnc) car- t collection on a pediatric patient, the spectra optia device never went into collecting white blood cells (wbcs).Per the customer, the device was custom primed with 340 ml of prbcs with hct 67% and all of it was processed.It was taking longer to establish the interface and at some point during the procedure, so the customer contacted tbct clinical support.The procedure endpoint was 3 x tbv.The optia stayed in establishing the interface the whole time and never flipped over to collecting wbcs.Per the customer no alarms occurred during the procedure.It was reported that the patients blood pressure dropped a little during procedure, but stabilized and they proceeded to manage it via the calcium fluid infusion.The procedure stopped after 2.5 hours without collecting any cells.Patient post procedure hct dropped to 13% and hgb 4.5.Per the customer, the patient required one unit of packed red blood cells (prbcs) (135mls) and one unit of platelets but otherwise stable.Per the customer they will collect the patient the following day.The customer declined to provide patient identifier.Patient age is not available at this time.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable history search for this lot showed no other reports for this failure mode.Correction: a letter was sent to the customer notifying them of the findings and the following recommendations: special attention is required when performing a custom blood prime for patients with a low tbv or low hct.A custom prime is a method for displacing the prime saline in the disposable tubing set with donor rbc.When the operator is prompted by the system to "enter data for custom prime," follow the instructions on the screens to perform the custom prime.These will appear after the tubing set has been primed with saline and the patient data are confirmed, and before the system instructs the operator to connect the patient.Follow local transfusion practices for filtering the unit of rbc prior to the custom prime.A volume of 300 ml, plus the blood warmer tubing volume (48ml for this procedure)of rbcs, should be processed for custom prime 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.A volume less than 300 ml is not optimal.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.If that volume of red cells is not enough to establish and maintain the interface, additional red cells must come from the patient.Rbc units should not be diluted to the patient¿s hematocrit.Doing so will result in less rbcs available in the set and can lead to depleting the patient of rbcs.In response to the ¿interface took too long to establish¿ alarm, the operator should lower the patient hct by 3 percentage points.Investigation is in process.A follow up report will be provided.
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Event Description
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The customer declined to provide patient age.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Investigation: 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 300 ml of priming blood to do a custom prime, or 340 ml if a blood warmer is used, as in this case.Based on internal studies [report fd- 0041, extracorporeal volume verification on spectra optia idl disposable kit, by terumo bct engineer, july 18th, 2011], the volume of priming blood in the channel at the completion of custom prime with a blood warmer in place is about 230 ml and the rbc volume when 340 ml of priming blood is used is as follows: rbc volume = 230 ml x 0.29 = 66.7 ml according to an internal study, the rbc volume in the extracorporeal circuit after spin-up and channel expansion, that is required to establish an interface, is estimated to be 90 ml.The difference in these two volumes, 90 ml and 66.7 ml, indicates that an additional amount of rbc volume from the patient (23.3 ml) was required for interface after the centrifugation began due to channel expansion after custom prime.Therefore, the patient's drop in hct was likely due to this loss of rbc volume, in addition to a hypervolemic fluid balance at the end of the procedure (122% from the rdf plus 7.28 ml of calcium gluconate).The operator made multiple attempts to adjust the inlet flow rate during the procedure.However, the system limited the flow rate to 9.7 ml/min with the ac infusion rate configured at 1.13 ml/min/ltbv.When a low inlet flow rate is used, it will take the system longer to process the required volume to establish the interface in pediatric patient with small tbv.A pediatric procedure being run at minimum inlet flow rate is forced by the system to run at minimum centrifuge speed.The dlog confirmed that the centrifuge speed was running at the minimum 550 rpm throughout the entire procedure.The system displayed a prompt 'packing factor may cause platelet depletion' (11:01) after the initial parameters were entered at the beginning of the procedure.This alerted the operator that the minimum centrifuge speed could result in a packing factor higher than specified by the target.The system did not generate another 'packing factor may cause platelet depletion' until 3 hours and 22 minutes into the procedure.The system only generates this alarm during the procedure, and not while the system is trying to establish the interface.The procedure was paused and terminated soon after the second alarm.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.10.Correction: field action 38 has been initiated to communicate: 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 internal capa has been initiated to address rbc depletion in small pediatric patients due to inadequate custom prime and inappropriate operator entries during a spectra optia cmnc procedure.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.10.Investigation: per internal medical review and analysis, there is no evidence of optia system failure, and the effect of the low hematocrit prime and positive fluid balance account for only a part of the apparent rbc and platelet losses.There is no information suggesting relevant underlying patient pathology.Although the magnitude of the rbc and platelet losses remain unexplained, the optia procedure, including the use of low hematocrit custom prime blood, likely contributed to both the rbc and platelet losses.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.A definitive root cause for the acute blood loss could not be determined.Possible causes include but are not limited to: - use of low hematocrit custom prime unit - patient's underlying disease - manner in which the blood sample was obtained and tested a definitive root cause for the acute platelet loss could not be determined.Possible causes include but are not limited to: - the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.- activation of platelets as a result of the patient's physiology.- when a dual-lumen catheter is used during calcium supplementation, there is some risk of recirculation.Calcium infused at the return site could be pumped into the extracorporeal circuit rather than to the patient.This could reverse some of the effect of the citrate anticoagulation and cause clumping in the circuit.- lower interface position due to use of low hematocrit custom prime, which resulted in greater platelet loss without rinseback.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.5, d.1, d.2, d.4, d.9, h.3, h.4, h.5, h.8 and h.10.Investigation: the patient's rbc loss during the procedure was calculated using the rbc loss model calculations in the internal hha.The volume of priming blood in the channel at the completion of custom prime with a blood warmer in place is about 230 ml and the rbc volume when 340 ml of priming blood is used is as follows: total extracorporeal rbc volume = 230 ml x 0.29 = 66.7 ml rbc volume in channel = 95 ml x 0.29 = 27.6 ml rbc volume in non-channel part of set = 135 ml x 0.29 = 39.2 ml 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 28 ml in the reservoir is infused into the patient at the same time as blood is being removed by the inlet pump.Channel volume during run = 144 ml + 0.033 x (550-500) = 145.7 ml channel rbc volume during run = 145.7 ml x 0.49 = 71.4 ml during the run after volume stabilization the volume of blood in the non-channel part of the set will contain 107 ml (135 ¿ 28) and the hematocrit is the same as the patient.Non-channel rbc volume = 107 ml x patient hct during run patient hct during run = ((630 ml x 0.29) + 67 ml - 71.4 ml) / 630 ml + 230 ml - 145.7 ml = 0.25 patient rbc loss during run = (channel rbc volume during run) + 67 x (patient hematocrit during run) - (set rbc volume post prime) patient's rbc loss during run = 71.4 ml + (67 ml x 0.25) - 67 = 21.2 ml according to the information in the clinical findings, the calcium gluconate was infused at 2.1 ml/hour via syringe pump (dose ordered 12mg/kg/hr).The total run time is 208 min (3.47 hrs) resulting in total 7.3 ml calcium over the course of the procedure.The patient's pre hct was 29% and post hct was 13%, representing a relative decrease of 55.2%.The pre platelet count was 68 x 10e3/ul and post platelet count was 22 x 10e3/ul, representing a relative loss of 67.6%.The model confirmed that additional 21 ml 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 25%.The patient received 139 ml ac (final fluid balance was 122%) and 7 ml of calcium gluconate.The additional hypervolemic fluid balance and crystalloid solution associated with calcium gluconate would not account for the degree of loss as reported by the customer (post hct 13%).Terumo bct field performance team engineer confirmed that there was no obvious clumping in the aims images.However, the operator made multiple adjustments to the ac ratio ranging from 12:1, 15:1, 12:1, 15:1 and then 11:1 throughout the procedure.It is possible that there was clumping elsewhere in the circuit but the operator did not mention it during the call.There were no level sensor alarms or centrifuge pressure alarms to suggest possible clumping either in the return reservoir or the channel.The aims images also show clear separation in the channel and there did not appear to be active hemolysis.The images also confirmed that the system was having difficulty establishing the interface and the interface remained low during the run.The low interface position would have a larger plasma layer, hence more platelets suspended in the plasma.It is possible that more platelets were left behind in the set without rinseback.Investigation is in process.A follow up report will be provided.
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Event Description
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The idl set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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