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

Catalog Number 12220

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Electrolyte Imbalance (2196)

Event Date 12/01/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the patient drinks an 8 oz glass of oj every morning including the day of the collection.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 they had to end the continuous mononuclear cell (cmnc) collection procedure after 24 minutes because they needed to take the patient for a ekg due to possible citrate toxicity.The citrate toxicity was resolved by increasing calcium iv infusion.The procedure was not continued based on the results of the ekg.The patient was admitted for observation and discharged.The customer declined to provide patient identifier.The collection set is not available because it was discarded by the customer.

Manufacturer Narrative

Investigation: per the customer, the patient drinks an 8 oz glass of oj every morning including the day of the collection.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.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 donor 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 reported that they had to end the continuous mononuclear cell (cmnc) collection procedure after 24 minutes because they needed to take the patient for a ekg due to possible citrate toxicity.The citrate toxicity was resolved by increasing calcium iv infusion.The procedure was not continued based on the results of the ekg.The patient was admitted for observation and discharged.The customer declined to provide patient identifier.The collection set is not available because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 16035380
• MDR Text Key: 306039970
• Report Number: 1722028-2022-00422
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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
• Report Date: 12/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 12220
• Device Lot Number: 2207223130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: No
• 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; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Female
• Patient Weight: 87 KG