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

Model Number 12320

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hypersensitivity/Allergic reaction (1907); Local Reaction (2035)

Event Date 08/19/2021

Event Type  Injury  

Event Description

The customer reported that when collecting stem cells for a mononuclear cell (mnc) collection with the same optia device, there was a serious citrate reaction, tetany and muscular fasciculations.The reaction was treated by drug intervention.Per the customer the patient was given 3x 10ml calciumglukonat (10%) i.V., 2ml dormicum (1mg/ml) i.V per the customer the patient was reported as symptom-free.Patient identifier is unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the spectra optia system was checked by a technical service engineer on 20 aug 2021.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the spectra optia system was checked by a technical service engineer on 20 aug 2021.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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.According to anticoagulation techniques in apheresis: from heparin to citrate and beyond, citrate related complications have been reported to occur in: 1.2% of donors during voluntary donation, 7.8% of patients undergoing therapeutic plasma exchange procedures, and 48% of patients undergoing large volume leukapheresis during peripheral blood progenitor cell collection.Symptoms of hypocalcemia and other citrate-induced metabolic abnormalities affect neuromuscular and cardiac function and range in severity from mild dysesthesias (most common) to tetany, seizures, and cardiac arrhythmias.The run data file (rdf) was analyzed for this event.Root cause: review of the run data files for the three cmnc procedures did not indicate a root cause for the reported citrate reaction of the donors and patient.The system operated as intended and the procedures were run within standard operating limits (i.E., not in ¿caution status¿).There were no signals or alarms in the dlog that would indicate any issues in the run, specifically the amount of ac delivered.The commanded ac pump speed and the measured ac pump speed were accurate and did not show any discrepancy in pump volume.Possible causes for the alleged reactions include but are not limited to subject physiology and/or subject sensitivity to the procedure.

Event Description

The customer reported that when collecting stem cells for a mononuclear cell (mnc) collection with the same optia device, there was a serious citrate reaction, tetany and muscular fasciculations.The reaction was treated by drug intervention.Per the customer the patient was given 3x 10ml calciumglukonat (10%) i.V., 2ml dormicum (1mg/ml) i.V per the customer the patient was reported as symptom-free.Due to eu personal data protection laws, the patient identifier 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
• MDR Report Key: 12599803
• MDR Text Key: 282610917
• Report Number: 1722028-2021-00317
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 10/08/2021

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 Expiration Date: 10/02/2022
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 2010223130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/08/2021
• Supplement Dates Manufacturer Received: 11/02/2021
• Supplement Dates FDA Received: 11/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 27 YR
• Patient Weight: 78