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

Model Number 12120

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

Patient Problems Dyspnea (1816); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 06/16/2021

Event Type  Injury  

Event Description

The customer reported that a donor had severe tetany with dyspnoea during a spectra optia procedure.Per the customer the patient is recovered.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Lot number 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 that a donor had severe tetany with dyspnoea during a spectra optia procedure.Per the customer the patient is recovered.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 b.6 and h.10.Lot number and expiry information are not available at this time.Investigation: the run data file (rdf) was analyzed for this event.Review of the run data file did not indicate a root cause for the reported citrate reaction of the 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.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: the run data file (rdf) was analyzed for this event.Review of the run data file did not indicate a root cause for the reported citrate reaction of the 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.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.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 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.Root cause: review of the run data file did not indicate a root cause for the reported citrate reaction of the donor.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.A root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined.Citrate 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 a donor had severe tetany with dyspnoea during a spectra optia procedure.Per the customer the patient is recovered.The collection set is not available for return because it was discarded by the customer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT 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: 13142493
• MDR Text Key: 286664997
• Report Number: 1722028-2022-00001
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583121201
• UDI-Public: 05020583121201
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12120
• Device Catalogue Number: 12120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/20/2022
• 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
• Treatment: ACD-A; ACD-A; ACD-A
• Patient Outcome(s): Other
• Patient Age: 28 YR
• Patient Sex: Male
• Patient Weight: 64 KG