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

Model Number 12320

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

Patient Problems Bradycardia (1751); Chest Pain (1776); Vomiting (2144); Paresthesia (4421)

Event Date 05/30/2023

Event Type  Injury  

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.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 paresthesia (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.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 then decreased to 0.80ml/min/ltbv at 25 minutes into the run.At 47 minutes, the ac infusion rate was increased to the original value of 1.2ml/min/ltbv.At 85 minutes, the procedure was paused, then ended by operator.Patient rinseback was not performed.If the patient is experiencing possible citrate reactions, the ac infusion rate can be decreased depending on patient tolerance.For specific patients, it may be beneficial to 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 inlet:ac ratio was set to the default value for cmnc procedures of 12 as this ratio will properly anticoagulant the system.There was no clumping observed in the aim images indicating this value was likely adequate.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.

Event Description

The customer reported that during a lymphocyte collection procedure on a spectra optia, after 6 minutes from the beginning of the procedure, the donor was given 2 sachets of oral calcium (each one, 500 mg ca + 200 iu vit d), as a prophylactic treatment.20 minutes into the procedure, the donor reported paresthesia, which was discussed with the medical staff and decided to administer a bolus of calcium gluconate (2 ampoules in 100 ml of ss); while the bolus was being prepared, the ac infusion rate was decreased to 0.8 ml/min/l vts for 20 minutes, during which time the donor reported improvement; the ac infusion rate was again increased to 1.2 ml/min/l vts.The customer reported that 30 minutes later, the donor reported chest pain, vomiting and registered hr 47.The procedure was paused and the medical staff evaluated the donor, who decided to do an electrocardiogram (where they observed sinus bradycardia), electrolytes, arterial gases and troponins.The customer reported that during the pause, the donor was given 1 ampoule of calcium and after 80 minutes of pause and no improvement in the donor the medical staff gave the indication to end the procedure without return.The customer reported that after 15 minutes of the patient being disconnected they started to vomit again.The patient was discharged the same day as the procedure.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 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 worldwide.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 paresthesia (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.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 then decreased to 0.80ml/min/ltbv at 25 minutes into the run.At 47 minutes, the ac infusion rate was increased to the original value of 1.2ml/min/ltbv.At 85 minutes, the procedure was paused, then ended by operator.Patient rinseback was not performed.If the patient is experiencing possible citrate reactions, the ac infusion rate can be decreased depending on patient tolerance.For specific patients, it may be beneficial to 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 inlet:ac ratio was set to the default value for cmnc procedures of 12 as this ratio will properly anticoagulant the system.There was no clumping observed in the aim images indicating this value was likely adequate.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 donor's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, and/or donor sensitivity to anticoagulant.

Event Description

The customer reported that during a lymphocyte collection procedure on a spectra optia, after 6 minutes from the beginning of the procedure, the donor was given 2 sachets of oral calcium (each one, 500 mg ca + 200 iu vit d), as a prophylactic treatment.20 minutes into the procedure, the donor reported paresthesia, which was discussed with the medical staff and decided to administer a bolus of calcium gluconate (2 ampoules in 100 ml of ss); while the bolus was being prepared, the ac infusion rate was decreased to 0.8 ml/min/l vts for 20 minutes, during which time the donor reported improvement; the ac infusion rate was again increased to 1.2 ml/min/l vts.The customer reported that 30 minutes later, the donor reported chest pain, vomiting and registered hr 47.The procedure was paused and the medical staff evaluated the donor, who decided to do an electrocardiogram (where they observed sinus bradycardia), electrolytes, arterial gases and troponins.The customer reported that during the pause, the donor was given 1 ampoule of calcium and after 80 minutes of pause and no improvement in the donor the medical staff gave the indication to end the procedure without return.The customer reported that after 15 minutes of the patient being disconnected they started to vomit again.The patient was discharged the same day as the procedure.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: 17195327
• MDR Text Key: 317805254
• Report Number: 1722028-2023-00219
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12320
• Device Catalogue Number: 4123201
• Device Lot Number: 2301236141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/23/2023
• 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: 33 YR
• Patient Sex: Male
• Patient Weight: 83 KG