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

Catalog Number 12320

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

Patient Problems Numbness (2415); Paresthesia (4421); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/04/2023

Event Type  Injury  

Event Description

The customer reported to terumo bct customer support that during a procedure a therapy patient had significant hypocalcemia that required hospitalization.Patient information and what medical intervention was required are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number, manufacture date and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during a procedure a therapy patient had significant hypocalcemia that required hospitalization.Per follow up with the customer, an adult male patient with a preexisting diagnosis of multiple myeloma experienced symptoms of severe hypocalcemia following the procedure.The patient experienced paresthesia resistant to iv calcium treatment ending with 'midwife's hands' and required transfer to the emergency room via ambulance.The patient received a total of 5.5 g of calcium gluconate as ordered by the physician in response to the reaction.Following the treatment there was a slight improvement in symptoms but still presence of midwife's hands.Due to eu personal data protection laws, the patient information is not available from the customer.The customer declined to provide the patient identifier.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images for the cmnc procedure did not indicate a specific root cause for the reported patient citrate reaction.It was confirmed that the ac infusion rate was set to 1.2ml/min/ltbv at the start of the procedure where it remained throughout the run.The procedure was paused for 3 minutes then 10 minutes twice towards the end of the run.At 199 minutes, the operator ended the procedure.Patient rinseback was not performed.If the patient is experiencing possible citrate reactions, the ac infusion rate can be decreased depending on patient tolerance.The ac infusion rate range is generally 0.8 1.2ml/min/ltbv.It is possible to go below and also above these values, however values above 1.2ml/min/ltbv put the system into caution status.For specific patients, it may be beneficial to decrease the ac infusion rate and remain at a lower value for the remainder of the procedure.In addition, lowering the speed of the inlet flow rate will subsequently lower the return flow rate, which can also slow the delivery of ac to the patient, however, will increase procedure time.The operator did attempt to lower the inlet flow rate from 80 to 40ml/min, however not until shortly before the run was ended.It is possible that decreasing the ac infusion rate and if needed the inlet flow rate may have help with issues experienced during this procedure.The inlet:ac ratio was set to the default value for cmnc procedures of 12 as this ratio will properly anticoagulant the system.At 50 minutes, the inlet:ac ratio was increased to 14 which puts less ac in the system.There was no clumping observed in the aim images indicating this value was likely adequate.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported to terumo bct customer support that during a procedure a therapy patient had significant hypocalcemia that required hospitalization.Per follow up with the customer, an adult male patient with a preexisting diagnosis of multiple myeloma experienced symptoms of severe hypocalcemia following the procedure.The patient experienced paresthesia resistant to iv calcium treatment ending with 'midwife's hands' and required transfer to the emergency room via ambulance.The patient received a total of 5.5 g of calcium gluconate as ordered by the physician in response to the reaction.Following the treatment there was a slight improvement in symptoms but still presence of ¿midwife¿s hands¿.Due to eu personal data protection laws, the patient information is not available from the customer.The customer declined to provide the patient identifier.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images for the cmnc procedure did not indicate a specific root cause for the reported patient citrate reaction.It was confirmed that the ac infusion rate was set to 1.2ml/min/ltbv at the start of the procedure where it remained throughout the run.The procedure was paused for 3 minutes then 10 minutes twice towards the end of the run.At 199 minutes, the operator ended the procedure.Patient rinseback was not performed.If the patient is experiencing possible citrate reactions, the ac infusion rate can be decreased depending on patient tolerance.The ac infusion rate range is generally 0.8 ¿ 1.2ml/min/ltbv.It is possible to go below and also above these values, however values above 1.2ml/min/ltbv put the system into caution status.For specific patients, it may be beneficial to decrease the ac infusion rate and remain at a lower value for the remainder of the procedure.In addition, lowering the speed of the inlet flow rate will subsequently lower the return flow rate, which can also slow the delivery of ac to the patient, however, will increase procedure time.The operator did attempt to lower the inlet flow rate from 80 to 40ml/min, however not until shortly before the run was ended.It is possible that decreasing the ac infusion rate and if needed the inlet flow rate may have help with issues experienced during this procedure.The inlet:ac ratio was set to the default value for cmnc procedures of 12 as this ratio will properly anticoagulant the system.At 50 minutes, the inlet:ac ratio was increased to 14 which puts less ac in the system.There was no clumping observed in the aim images indicating this value was likely adequate.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paraesthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.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 additional information in h.6 and h.10.Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The run data file (rdf) was analyzed for this event.Review of the run data file and aim images for the cmnc procedure did not indicate a specific root cause for the reported patient citrate reaction.It was confirmed that the ac infusion rate was set to 1.2ml/min/ltbv at the start of the procedure where it remained throughout the run.The procedure was paused for 3 minutes then 10 minutes twice towards the end of the run.At 199 minutes, the operator ended the procedure.Patient rinseback was not performed.If the patient is experiencing possible citrate reactions, the ac infusion rate can be decreased depending on patient tolerance.The ac infusion rate range is generally 0.8 ¿ 1.2ml/min/ltbv.It is possible to go below and also above these values, however values above 1.2ml/min/ltbv put the system into caution status.For specific patients, it may be beneficial to decrease the ac infusion rate and remain at a lower value for the remainder of the procedure.In addition, lowering the speed of the inlet flow rate will subsequently lower the return flow rate, which can also slow the delivery of ac to the patient, however, will increase procedure time.The operator did attempt to lower the inlet flow rate from 80 to 40ml/min, however not until shortly before the run was ended.It is possible that decreasing the ac infusion rate and if needed the inlet flow rate may have help with issues experienced during this procedure.The inlet:ac ratio was set to the default value for cmnc procedures of 12 as this ratio will properly anticoagulant the system.At 50 minutes, the inlet:ac ratio was increased to 14 which puts less ac in the system.There was no clumping observed in the aim images indicating this value was likely adequate.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: a root cause assessment was performed for this complaint.A definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and or patient sensitivity to anticoagulant.

Event Description

The customer reported to terumo bct customer support that during a procedure a therapy patient had significant hypocalcemia that required hospitalization.Per follow up with the customer, an adult male patient with a preexisting diagnosis of multiple myeloma experienced symptoms of severe hypocalcemia following the procedure.The patient experienced paresthesia resistant to iv calcium treatment ending with 'midwife's hands' and required transfer to the emergency room via ambulance.The patient received a total of 5.5 g of calcium gluconate as ordered by the physician in response to the reaction.Following the treatment there was a slight improvement in symptoms but still presence of ¿midwife¿s hands¿.Due to eu personal data protection laws, the patient information is not available from the customer.The customer declined to provide the patient identifier.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: 17886130
• MDR Text Key: 325088167
• Report Number: 1722028-2023-00330
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12320
• Device Lot Number: 2303093141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/09/2023
• 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): Required Intervention; Other
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 83 KG