MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Catalog Number 4123201

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Arrhythmia (1721); Vomiting (2144); Syncope/Fainting (4411)

Event Date 11/04/2023

Event Type  Injury  

Event Description

The customer reported to terumo bct customer support that after a second apheresis procedure the patients iron level was low and they received an iv iron infusion directly after the apheresis procedure.The patient felt extremely well post apheresis the first procedure, and no longer had any colitis side effects.The customer reported that once the patient was home they reported they were vomiting for several days and returned to the emergency room as she was unconscious, had heart rhythm disturbances, and was close to multi organ failure.The patient received infusions and is stable.Patient weight is unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images did not show a specific root cause for the reported patient reaction after the cmnc procedure used to perform lymphocytopheresis.It was noted that there were numerous access pressure alarms throughout the procedure, the patient was anemic (hct 20%) and a large volume was removed from the patient (b)(6) leaving the patient with a 97% fluid balance.It is possible that these factors contributed to the reported patients reaction.It was also stated that the patient received an iv iron infusion directly after the apheresis procedure through the optia return line manifold.The reported patient symptoms included vomiting, low blood pressure and heart rhythm disturbances, which can be characteristic of an iron overload.In total, there were 53 access pressure alarms (50 inlet and 2 return) during the procedure.Excessive pressure alarms can result in decreased collection efficiency 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.The collect pump is running during this time and the collect valve remains open, so cells are being collected; however, the system is not collecting at the target cp during interface setup and may not be efficiently collecting the desired target cells.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.The inlet flow rate was set at 30ml/min for the majority of the run and lowered it only at the end of the run.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.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that after a second apheresis procedure the patients iron level was low and they received an iv iron infusion directly after the apheresis procedure.The patient felt extremely well post apheresis the first procedure, and no longer had any colitis side effects.The customer reported that once the patient was home they reported they were vomiting for several days and returned to the emergency room as she was unconscious , had heart rhythm disturbances, and was close to multi organ failure.The patient received infusions and is stable.Patient's weight was obtained from the run data file (rdf).The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported to terumo bct customer support that after a second apheresis procedure the patients iron level was low and they received an iv iron infusion (fermed / 100 mg (1 ampule) the ampule was added to 250 ml nacl.Then in a drip, the 350 ml was given in 30 min) directly after the apheresis procedure.The patient felt extremely well post apheresis the first procedure (two weeks prior), and no longer had any colitis side effects.The customer reported that once the patient was home they reported they were vomiting for several days and returned to the emergency room as she was unconscious , had heart rhythm disturbances, and was close to multi organ failure.The patient received infusions and is stable.Per follow-up with the patient's mother she received antibiotics, iron nutrition, fluids, oxycodone, and potassium.The problematic procedure was the third optia procedure for the patient.Thereafter, she had recently received a further 2 procedures without issue.Patient¿s weight was obtained from the run data file (rdf).Due to eu personal data protection laws, further information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the attending physician, the reaction could no have been due to iron overload.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images did not show a specific root cause for the reported patient reaction after the cmnc procedure used to perform lymphocytopheresis.It was noted that there were numerous access pressure alarms throughout the procedure, the patient was anemic (hct 20%) and a large volume was removed from the patient (895mls) leaving the patient with a 97% fluid balance.It is possible that these factors contributed to the reported patient¿s reaction.It was also stated that the patient received an iv iron infusion directly after the apheresis procedure through the optia return line manifold.The reported patient symptoms included vomiting, low blood pressure and heart rhythm disturbances, which can be possible side effects of an iron transfusion.In total, there were 53 access pressure alarms (50 inlet and 2 return) during the procedure.Excessive pressure alarms can result in decreased collection efficiency 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.The collect pump is running during this time and the collect valve remains open, so cells are being collected; however, the system is not collecting at the target cp during interface setup and may not be efficiently collecting the desired target cells.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.The inlet flow rate was set at 30ml/min for the majority of the run and lowered it only at the end of the run.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.Additional follow up with the reporting physician confirmed that this procedure was the third optia procedure for the patient.Thereafter, she had recently received a further 2 procedures without issue.Iron was infused to the patient in this instance because her values were low, via fermed 100 mg (1 ampule, 100ml) added to 250ml saline and delivered by drip over 30 minutes while disconnected from the optia device.The physician does not believe the patient¿s reaction is symptomatic of iron overload and no chelating agents were given.The physician also stated that iron infusion was not required for the prior procedure.The patient was confirmed to have historical low hct values.The hct was adjusted from 29 to 20% during the procedure due to a low interface.The patient¿s pre and post hct were 29.8% and 31.6% respectively.The post-run ferritin value was 6 mg/l.The regional account manager was able to confirm details of the infusions given to the patient by the external hospital.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 this complaint.Based on the available information a definitive root cause could not be determined based on the available information a definitive root cause could not be determined.The symptoms reported are common side effects of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the rate of ac infusion, the length of the procedure, the patient's sensitivity to the procedure and/or the hemodynamic stress of the procedure.It could also be related to possible side effects of iron infusion.

Event Description

The customer reported to terumo bct customer support that after a second apheresis procedure the patients iron level was low and they received an iv iron infusion (fermed / 100 mg (1 ampule) the ampule was added to 250 ml nacl.Then in a drip, the 350 ml was given in 30 min) directly after the apheresis procedure.The patient felt extremely well post apheresis the first procedure (two weeks prior), and no longer had any colitis side effects.The customer reported that once the patient was home they reported they were vomiting for several days and returned to the emergency room as she was unconscious , had heart rhythm disturbances, and was close to multi organ failure.The patient received infusions and is stable.Per follow-up with the patient's mother she received antibiotics, iron nutrition, fluids, oxycodone, and potassium.The problematic procedure was the third optia procedure for the patient.Thereafter, she had recently received a further 2 procedures without issue.Patient¿s weight was obtained from the run data file (rdf).Due to eu personal data protection laws, further information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information in b.7 and h.11.Updated information is provided in h.11.Investigation: per the attending physician, the reaction could no have been due to iron overload.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images did not show a specific root cause for the reported patient reaction after the cmnc procedure used to perform lymphocytopheresis.It was noted that there were numerous access pressure alarms throughout the procedure, the patient was anemic (hct 20%) and a large volume was removed from the patient (895mls) leaving the patient with a 97% fluid balance.It is possible that these factors contributed to the reported patient¿s reaction.It was also stated that the patient received an iv iron infusion directly after the apheresis procedure through the optia return line manifold.The reported patient symptoms included vomiting, low blood pressure and heart rhythm disturbances, which can be possible side effects of an iron transfusion.In total, there were 53 access pressure alarms (50 inlet and 2 return) during the procedure.Excessive pressure alarms can result in decreased collection efficiency 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.The collect pump is running during this time and the collect valve remains open, so cells are being collected; however, the system is not collecting at the target cp during interface setup and may not be efficiently collecting the desired target cells.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.The inlet flow rate was set at 30ml/min for the majority of the run and lowered it only at the end of the run.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.Additional follow up with the reporting physician confirmed that this procedure was the third optia procedure for the patient.Thereafter, she had recently received a further 2 procedures without issue.Iron was infused to the patient in this instance because her values were low, via fermed 100 mg (1 ampule, 100ml) added to 250ml saline and delivered by drip over 30 minutes while disconnected from the optia device.The physician does not believe the patient¿s reaction is symptomatic of iron overload and no chelating agents were given.The physician also stated that iron infusion was not required for the prior procedure.The patient was confirmed to have historical low hct values.The hct was adjusted from 29 to 20% during the procedure due to a low interface.The patient¿s pre and post hct were 29.8% and 31.6% respectively.The post-run ferritin value was 6 mg/l.The regional account manager was able to confirm details of the infusions given to the patient by the external hospital.The following published literature articles address the risk of iron depletion in the removed plasma and waste product.According to shadi yarandi, md, et al.In a publication titled the prevalence of subclinical iron deficiency in patients with irritable bowel syndrome (article 1869, the american journal of gastroenterology), the data suggests that the prevalence of subclinical iron deficiency is high in patients with ibs, regardless of race or subtype.According to lovisa widbom et al.In a journal article titled patients developing inflammatory bowel disease have iron deficiency and lower plasma ferritin years before diagnosis: a nested case-control study (european journal of gastroenterology & hepatology 2020, 32:1147¿1153).The authors concluded that lower ferritin was associated with higher risk for developing ibd in a prospective setting.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined based on the available information a definitive root cause could not be determined.The symptoms reported are common side effects of therapeutic apheresis procedures.They are typically caused by the patient's disease state, the rate of ac infusion, the length of the procedure, the patient's sensitivity to the procedure and/or the hemodynamic stress of the procedure.It could also be related to possible side effects of iron infusion.

Manufacturer Narrative

This report is being filed to provide additional information in b.6 and h.11.Corrected information in h.11.Investigation: per the attending physician, the reaction could no have been due to iron overload.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images did not show a specific root cause for the reported patient reaction after the cmnc procedure used to perform lymphocytopheresis.It was noted that there were numerous access pressure alarms throughout the procedure, the patient was anemic (hct 20%) and a large volume was removed from the patient (895mls) leaving the patient with a 97% fluid balance.It is possible that these factors contributed to the reported patient¿s reaction.It was also stated that the patient received an iv iron infusion directly after the apheresis procedure through the optia return line manifold.The reported patient symptoms included vomiting, low blood pressure and heart rhythm disturbances, which can be possible side effects of an iron transfusion.In total, there were 53 access pressure alarms (50 inlet and 2 return) during the procedure.Excessive pressure alarms can result in decreased collection efficiency 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.The collect pump is running during this time and the collect valve remains open, so cells are being collected; however, the system is not collecting at the target cp during interface setup and may not be efficiently collecting the desired target cells.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.The inlet flow rate was set at 30ml/min for the majority of the run and lowered it only at the end of the run.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.Additional follow up with the reporting physician confirmed that this procedure was the third optia procedure for the patient.Thereafter, she had recently received a further 2 procedures without issue.Iron was infused to the patient in this instance because her values were low, via fermed 100 mg (1 ampule, 100ml) added to 250ml saline and delivered by drip over 30 minutes while disconnected from the optia device.The physician does not believe the patient¿s reaction is symptomatic of iron overload and no chelating agents were given.The physician also stated that iron infusion was not required for the prior procedure.The patient was confirmed to have historical low hct values.The hct was adjusted from 29 to 20% during the procedure due to a low interface.The patient¿s pre and post hct were 29.8% and 31.6% respectively.The post-run ferritin value was 6 mg/l.The regional account manager was able to confirm details of the infusions given to the patient by the external hospital.The following published literature articles address the risk of iron depletion in the removed plasma and waste product.According to shadi yarandi, md, et al.In a publication titled the prevalence of subclinical iron deficiency in patients with irritable bowel syndrome (article 1869, the american journal of gastroenterology), the data suggests that the prevalence of subclinical iron deficiency is high in patients with ibs, regardless of race or subtype.According to lovisa widbom et al.In a journal article titled patients developing inflammatory bowel disease have iron deficiency and lower plasma ferritin years before diagnosis: a nested case-control study (european journal of gastroenterology & hepatology 2020, 32:1147¿1153).The authors concluded that lower ferritin was associated with higher risk for developing ibd in a prospective setting.Corrected root cause:a root cause assessment was performed for the lower iron post procedure which required medical intervention in the form of an iron infusion.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: * patient's disease state * exacerbation of iron deficiency by removing large volume of plasma removed and undergoing multiple procedures over a relatively short period of time.Cause for the subsequent vomiting, heart arrythmia, loss of consciousness and near multi-organ failure in the subsequent days after the procedure is undetermined but may be related to the patient¿s underlying condition, the patient¿s gastroenteritis infection, an unknown medical event or an undisclosed medical condition.

Event Description

The customer reported to terumo bct customer support that after a second apheresis procedure the patients iron level was low and they received an iv iron infusion (fermed / 100 mg (1 ampule) the ampule was added to 250 ml nacl.Then in a drip, the 350 ml was given in 30 min) directly after the apheresis procedure.The patient felt extremely well post apheresis the first procedure (two weeks prior), and no longer had any colitis side effects.The customer reported that once the patient was home they reported they were vomiting for several days and returned to the emergency room as she was unconscious , had heart rhythm disturbances, and was close to multi organ failure.The patient received infusions and is stable.Per follow-up with the patient's mother she received antibiotics, iron nutrition, fluids, oxycodone, and potassium.The problematic procedure was the third optia procedure for the patient.Thereafter, she had recently received a further 2 procedures without issue.Patient¿s weight was obtained from the run data file (rdf).Due to eu personal data protection laws, further information is not available from the customer.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 18233575
• MDR Text Key: 329297895
• Report Number: 1722028-2023-00398
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 11/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4123201
• Device Lot Number: 2307213141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 12/12/2023; 02/02/2024; 04/09/2024; 04/18/2024
• Supplement Dates FDA Received: 12/19/2023; 02/05/2024; 04/12/2024; 05/07/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/21/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 YR
• Patient Sex: Female
• Patient Weight: 55 KG