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 Dyspnea (1816); Muscular Rigidity (1968); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 09/08/2023

Event Type  Injury  

Event Description

The customer called terumo bct customer support and reported that a patient had a citrate reaction during a continuous mononuclear cell collection (cmnc) procedure.The customer paused the procedure and administered tums and increased the calcium gluconate 5 gm iv in 100 ml normal saline and then ended the procedure.The infusion was given at 60 ml/hr for approximately 90 min total.Patient was experiencing shortness of breath, muscle rigidity and spasms, unable to talk, and a tingling in mouth and cheeks.Per the customer there was additional medication given not part of the original planned protocol.The customer is only aware that the patient received magnesium & potassium, but does not have access to this information.The patient was stable prior to the procedure.The patients was discharged home.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.Investigation is in process, a follow-up report will be provided.

Event Description

The customer called terumo bct customer support and reported that a patient had a citrate reaction during a continuous mononuclear cell collection (cmnc) procedure.The customer paused the procedure and administered tums and increased the calcium gluconate 5 gm iv in 100 ml normal saline and then ended the procedure.The infusion was given at 60 ml/hr for approximately 90 min total.Patient was experiencing shortness of breath, muscle rigidity and spasms, unable to talk, and a tingling in mouth and cheeks.Per the customer there was additional medication given not part of the original planned protocol.The customer is only aware that the patient received magnesium & potassium, but does not have access to this information.The patient was stable prior to the procedure.The patients was discharged home.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: the device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.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.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.Investigation is in process, a follow-up report will be provided.

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.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A dlog analysis was not performed since the customer did not run the procedure in caution mode where there the ac infusion rate could exceed the recommended range and safety limit of 1.2 ml/min/ltbv.The customer wanted to discuss with terumo bct regarding the use of anticoagulant, specifically the bare minimum acda that can be used in conjunction with heparin.The physician wanted to perform another collection using heparin/acda.Terumo bct medical affairs informed the customer that terumo does not have an in house protocol or guidance related to the use of heparin/acda; our protocols are validated using acda only.Preventive maintenance was completed per manufactures specifications to verify that the machine was functioning as intended.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.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.Root cause: a root cause assessment was performed for the reported citrate reactions.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the ac infusion rate.

Event Description

The customer called terumo bct customer support and reported that a patient had a citrate reaction during a continuous mononuclear cell collection (cmnc) procedure.The customer paused the procedure and administered tums and increased the calcium gluconate 5 gm iv in 100 ml normal saline and then ended the procedure.The infusion was given at 60 ml/hr for approximately 90 min total.Patient was experiencing shortness of breath, muscle rigidity and spasms, unable to talk, and a tingling in mouth and cheeks.Per the customer there was additional medication given not part of the original planned protocol.The customer is only aware that the patient received magnesium & potassium, but does not have access to this information.The patient was stable prior to the procedure.The patients was discharged home.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: 17877102
• MDR Text Key: 324994657
• Report Number: 1722028-2023-00328
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2023

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: 2305096141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/11/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 10/27/2023; 11/08/2023
• Supplement Dates FDA Received: 10/30/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/09/2023
• 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): Other
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 80 KG