| Catalog Number |
4121201 |
| Medical Device Problem Codes |
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
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| Health Effect - Clinical Code |
Tachycardia (2095)
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| Date of Event |
07/11/2024
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Type of Reportable Event
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Serious Injury
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Additional Manufacturer Narrative
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Investigation: lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: walker, h., o¿reilly, e., millard, z., cusack, b., duncan, a., clucas, l., fleming, j., hughes, d., greenway, a., & metz, d.(2024).Small but mighty: case report and practical guidance for peripheral blood stem cell collection in small infants.Journal of clinical apheresis, 39(4).Https://doi.Org/10.1002/jca.22141.
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Event or Problem Description
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Per journal article "small but mighty: case report and practical guidance for peripheral blood stem cell collection in small infants", by walker, h., o¿reilly, e., millard, z., cusack, b., duncan, a., clucas, l., fleming, j., hughes, d., greenway, a., & metz, d., patient a was diagnosed with an atypical teratoid rhabdoid tumor, a central nervous system (cns) tumor, at approximately four months of age after presenting with vomiting and failure to thrive.The infant was referred to the apheresis service for peripheral stem cell mobilization and collection in 2022, weighing 5 kg.On day 1 of collection, optia system recommended run values were used, with exception of the operator manually adjusting (increasing) the anticoagulation (ac) infusion rate to 0.9 ml/min/l total blood volume (tbv), allowing an inlet flow rate to 5 ml/min as required for continuous mononuclear cell collection (cmnc) procedure as per the operator's manual.The inlet:ac ratio was 12:1 and the collect flow rate was 0.5 ml/min.Blood warmer tubing (25 ml) was added to the circuit.During collection, the infant was unsettled, and with persistent sinus tachycardia.Interventions included paracetamol, increasing the nasogastric feed rate, wrapping in warm blankets, and a small saline fluid bolus of 5 ml/kg.The interface on day 1 took approximately 52 min to establish.Multiple ¿low inlet pressure¿ alarms occurred, with frequent pauses in inlet flow.These alarms were associated with patient irritability and movement causing the vascath to occlude, resulting in inadequate inlet flow to the optia.No visible clot or clumping was noted in the circuit at this time.The vascath was manually assessed by nursing staff for patency and was noted to be flushing and yielding with ease while the patient was settled.However, as the procedure progressed a new alarm alerted, causing the procedure to pause, stating ¿collect line below bag was obstructed.¿ the reservoir in the circuit was noted to be dilute with minimal red blood cells passively flowing into the reservoir the inlet:ac ratio was then decreased to 6:1, and ac infusion rate was increased to 1.8 ml/min/l tbv to achieve an inlet flow rate of 5.2 ml/min.The high ac infusion rate caused the optia to run in ¿caution status¿ and a calcium gluconate infusion was commenced at 0.11 mmol/kg/h.Alarms for ¿collect line was obstructed below bag¿ were encountered two times more and after consultation with a terumo clinical specialist, the apheresis procedure was aborted for the day early termination of the procedure after 3 hrs of collection resulted in minimal cd34 volume being collected, a total of 0.41 x 10^6/kg cd34 cells, well below the target required clinically.Post procedure, the circuit was unloaded and visually inspected.No visible clot was identified; however, it is assumed the obstruction to the circuit was caused by clotting resulting from frequent pauses to the procedure during alarms.Given issues on day 1 of collection; with the infant being unsettled and tachycardic, several changes were made to minimize this occurring, with enteral bolus feeding for satiety and oxycodone prior to commencement.To improve patency of the circuit from the outset, the ac infusion rate was commenced at 2.0 ml/min/l tbv, with initial inlet:ac ratio of 8:1 and an inlet flow rate of 7.6 ml/min.The optia ran in ¿caution status¿ as a consequence of the high ac infusion rate; therefore, an intravenous calcium gluconate infusion was administered throughout the entirety of procedure, again at 0.11 mmol/kg/h.The interface was established significantly faster on day two, at approximately 20 min.The patient was very settled throughout the second day of the procedure and the vascath remained patent, with no alarms encountered on the optia.The uneventful apheresis procedure successfully processed two blood volumes within 3.5 h.The patient had no episodes of tachycardia, hypocalcemia, or any other complications on day 2 of collection.Tachycardia is a commonly reported adverse effect of apheresis in small infants, as indeed was seen on the first collection day in this case, with multiple potential etiologies including intravascular volume depletion.Specific details, such as patient outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.The collection set is not available for return because it was discarded by the customer.
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Additional Manufacturer Narrative
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This report is being filed to provide additional information in b.5, d.1, h.6 and h.11.Investigation: overview: an investigation was conducted for journal article that references terumo bct product.Journal article, titled ¿small but mighty: case report and practical guidance for peripheral blood stem cell collection in small infants¿ by metz et al.Jul 2024, was reviewed with primary purpose of screening for allegations of terumo bct device causing or contributing to death/injury or device malfunctions.Product evaluation: part evaluation is not feasible for this journal article investigation because there are many months between collection of data, to peer review, to final publication.Investigational details: the purpose of the journal article study is noted in the article abstract: abstract modern apheresis devices, with increased procedural precision, automation, and monitoring, have been shown to allow for safe delivery of apheresis therapies in young children.Medical advances are increasing demand for apheresis procedures like mononuclear cell collection in infants <10 kg, including stemcell supported chemotherapy, cell collection for chimeric antigen receptor t cell development, and now ex vivo gene therapies for rare genetic diseases.Nevertheless, safe delivery in small infants involves a range of unique considerations and challenges, beyond just size, and experience will vary between centers.In this case report we describe our experience performing mononuclear cell collection in our smallest patient to date and outline a practice guidelines developed following a literature review and discussion with both international experts and device representatives.This case may help to inform other clinicians aiming to provide apheresis care to very small infants in their own centers.Summary of terumo bct product in relation to the journal article: the authors describe their recent experience at a tertiary pediatric center in melbourne, australia, performing stem collection in their smallest infant to date (5 kg).Patient a was diagnosed with an atypical teratoid rhabdoid tumor, a cns tumor, at approximately 4 months of age after presenting with vomiting and failure to thrive.The infant was referred to the apheresis service for peripheral stem cell mobilization and collection in 2022, weighing 5 kg.Treatment was commenced according to the children's oncology group protocol acns0334 using high-dose chemotherapy with autologous stem cell rescue in three tandem ¿consolidation blocks.¿ thus, stem cell collection was required, with target cd34 of 6 to 15 _ 106/kg.Regarding terumo bct product, optia, persistent tachycardia, which was treated with a bolus of saline, multiple inlet pressure alarms and collect bag obstructed alarms were reported.Apheresis was commenced after 5 days of granulocyte-colony stimulating factor (g-csf) 10 mcg/kg, with vascath insertion the night prior.A 7fr double lumen vascath was inserted into the left internal jugular vein when the peripheral cd34 count was 26 _ 103/ml.The apheresis procedure was undertaken in the pediatric intensive care unit (picu) to ensure adequate capacity for monitoring and management of potential hemodynamic instability.On day 1 of collection, optia system recommended run values were used, with exception of the operator manually adjusting (increasing) the anticoagulation (ac) infusion rate to 0.9 ml/min/l total blood volume (tbv), allowing an inlet flow rate to 5 ml/min as required for cmnc procedure as per the operator's manual.The inlet:ac ratio was 12:1 and the collect flow rate was 0.5 ml/min.Blood warmer tubing (25 ml) was added to the circuit.During collection, the infant was unsettled, and with persistent sinus tachycardia.Interventions included paracetamol, increasing the nasogastric feed rate, wrapping in warm blankets, and a small saline fluid bolus of 5 ml/kg.The interface on day 1 took approximately 52 min to establish.Multiple ¿low inlet pressure¿ alarms occurred, with frequent pauses in inlet flow.These alarms were associated with patient irritability and movement causing the vascath to occlude, resulting in inadequate inlet flow.No visible clot or clumping was noted in the circuit at this time.The vascath was manually assessed by nursing staff for patency and was noted to be flushing and yielding with ease while the patient was settled.However, as the procedure progressed a new alarm alerted, causing the procedure to pause, stating ¿collect line below bag was obstructed.¿ the reservoir in the circuit was noted to be dilute with minimal red blood cells passively flowing into the reservoir.The inlet:ac ratio was then decreased to 6:1, and ac infusion rate was increased to 1.8 ml/min/l tbv to achieve an inlet flow rate of 5.2 ml/min.The high ac infusion rate caused the optia to run in ¿caution status¿.And a calcium gluconate infusion was commenced at 0.11 mmol/kg/h.Alarms for ¿collect line was obstructed below bag¿ were encountered two times more and after consultation with a terumo clinical specialist, the apheresis procedure was aborted for the day.These issues and early termination of the procedure after 3 h of collection, resulted in minimal cd34 volume being collected, a total of 0.41 _ 106/kg cd34 cells, well below the target required clinically.Post procedure, the circuit was unloaded and visually inspected.No visible clot was identified; however, it is assumed the obstruction to the circuit was caused by clotting resulting from frequent pauses to the procedure during alarms.The patient was very settled throughout the second day of the procedure and the vascath remained patent, with no alarms encountered on the optia.The uneventful apheresis procedure successfully processed two blood volumes within 3.5 h.The patient had no episodes of tachycardia, hypocalcemia, or any other complications on day 2 of collection.The total cd34 collected was 6.3_ 106/kg, adequate for the three returns required clinically.Since this was a journal publication accepted in early 2024, to describe a mononuclear cell collection in a 5 kg patient with focus on outlining practice guidelines to inform other clinicians aiming to provide apheresis care to very small infants in their own centers, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.According to therapeutic apheresis: a physician's handbook, the rate of adverse events during therapeutic apheresis is 4% to 5%, with the risk being slightly higher during the first procedure, and varying considerably with the type of procedure.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension root cause: a root cause assessment was performed for the adverse reactions (tachycardia).The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.The authors acknowledged the occurrence of multiple ¿low inlet pressure¿ alarms followed by an alert that the ¿collect line was obstructed ¿.The most common source of pressure alarms is when the inlet flow rate is set too high for the given patient access or the patient access is not properly positioned.In response to these alarms, it is suggested to check the positioning of the patient access and lower the inlet flow rate.In some cases, it may be necessary to run at a lower inlet flow rate to avoid the alarms.Ensuring the patient access is appropriately sized, nothing is blocking the access, the inlet flow rate is not too high, and generally controlling access issues is important as these can greatly contribute to the success of a procedure.These alarms were associated with patient irritability and movement causing the vascath to occlude, resulting in inadequate inlet flow.Pressure alarms can contribute to the severity of clumping during a procedure as they cause the pumps to pause and the system to re-establish the interface, which in turn affects how well the buffy coat is separated and the flow of fluids through the set.The system also is not efficiently moving blood through the set and stagnant blood tends to contribute to platelet clumping so the product entering the collect bag may contain microaggregates and platelet clumps.The customer reported the occurrence ofpump pauses during the run, the ac pump pumps ac to the inlet manifold where it mixes with the patient¿s blood and is then pumped to the channel where the blood is separated.Excessive pump pauses, historically caused by access issues, or pump pauses of an extended time have the potential to result in coagulation in the access line, this non-coagulated portion could then be pulled into the system via the inlet line and consequently clump together, fully, or partially occluding the disposable set which may have resulted in the ¿collect line below bag was obstructed¿ alarm.However, this cannot be definitively determined.Excessive coagulation can also be caused by the patient disease state and/or blood physiology.The uneventful apheresis procedure successfully processed two blood volumes within 3.5 h on the second day.Citation: walker, h., o¿reilly, e., millard, z., cusack, b., duncan, a., clucas, l., fleming, j., hughes, d., greenway, a., & metz, d.(2024).Small but mighty: case report and practical guidance for peripheral blood stem cell collection in small infants.Journal of clinical apheresis, 39(4).Https://doi.Org/10.1002/jca.22141.
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Event or Problem Description
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Per journal article "small but mighty: case report and practical guidance for peripheral blood stem cell collection in small infants", by walker, h., o¿reilly, e., millard, z., cusack, b., duncan, a., clucas, l., fleming, j., hughes, d., greenway, a., & metz, d., patient a was diagnosed with an atypical teratoid rhabdoid tumor, a central nervous system (cns) tumor, at approximately four months of age after presenting with vomiting and failure to thrive.The infant was referred to the apheresis service for peripheral stem cell mobilization and collection in 2022, weighing 5 kg.On day 1 of collection, optia system recommended run values were used, with exception of the operator manually adjusting (increasing) the anticoagulation (ac) infusion rate to 0.9 ml/min/l total blood volume (tbv), allowing an inlet flow rate to 5 ml/min as required for continuous mononuclear cell collection (cmnc) procedure as per the operator's manual.The inlet:ac ratio was 12:1 and the collect flow rate was 0.5 ml/min.Blood warmer tubing (25 ml) was added to the circuit.During collection, the infant was unsettled, and with persistent sinus tachycardia.Interventions included paracetamol, increasing the nasogastric feed rate, wrapping in warm blankets, and a small saline fluid bolus of 5 ml/kg.The interface on day 1 took approximately 52 min to establish.Multiple ¿low inlet pressure¿ alarms occurred, with frequent pauses in inlet flow.These alarms were associated with patient irritability and movement causing the vascath to occlude, resulting in inadequate inlet flow to the optia.No visible clot or clumping was noted in the circuit at this time.The vascath was manually assessed by nursing staff for patency and was noted to be flushing and yielding with ease while the patient was settled.However, as the procedure progressed a new alarm alerted, causing the procedure to pause, stating ¿collect line below bag was obstructed.¿ the reservoir in the circuit was noted to be dilute with minimal red blood cells passively flowing into the reservoir the inlet:ac ratio was then decreased to 6:1, and ac infusion rate was increased to 1.8 ml/min/l tbv to achieve an inlet flow rate of 5.2 ml/min.The high ac infusion rate caused the optia to run in ¿caution status¿ and a calcium gluconate infusion was commenced at 0.11 mmol/kg/h.Alarms for ¿collect line was obstructed below bag¿ were encountered two times more and after consultation with a terumo clinical specialist, the apheresis procedure was aborted for the day early termination of the procedure after 3 hrs of collection resulted in minimal cd34 volume being collected, a total of 0.41 x 10^6/kg cd34 cells, well below the target required clinically.Post procedure, the circuit was unloaded and visually inspected.No visible clot was identified; however, it is assumed the obstruction to the circuit was caused by clotting resulting from frequent pauses to the procedure during alarms.Given issues on day 1 of collection; with the infant being unsettled and tachycardic, several changes were made to minimize this occurring, with enteral bolus feeding for satiety and oxycodone prior to commencement.To improve patency of the circuit from the outset, the ac infusion rate was commenced at 2.0 ml/min/l tbv, with initial inlet:ac ratio of 8:1 and an inlet flow rate of 7.6 ml/min.The optia ran in ¿caution status¿ as a consequence of the high ac infusion rate; therefore, an intravenous calcium gluconate infusion was administered throughout the entirety of procedure, again at 0.11 mmol/kg/h.The interface was established significantly faster on day two, at approximately 20 min.The patient was very settled throughout the second day of the procedure and the vascath remained patent, with no alarms encountered on the optia.The uneventful apheresis procedure successfully processed two blood volumes within 3.5 h.The patient had no episodes of tachycardia, hypocalcemia, or any other complications on day 2 of collection.Tachycardia is a commonly reported adverse effect of apheresis in small infants, as indeed was seen on the first collection day in this case, with multiple potential etiologies including intravascular volume depletion.Specific details, such as patient outcome and gender, were not included in the article for the event.The collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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