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

Model Number 12220

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

Patient Problems Rash (2033); Unspecified Respiratory Problem (4464)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure the patient showed signs of respiratory arrest after approximately one plasma volume exchanged.The patient presented with labial commissure lateralization previously manifested and treated with calcium gluconate and a rash treated with diphenhydramine.But the symptoms didn¿t disappear.The medical team also administrated hydrocortisone with no improvement, and finally they finished the procedure without blood devolution and with only one plasma volume exchanged.It was planned to be a 1.5 plasma volume exchanged.Per the customer, after resuscitation using amines, the patient had a low calcium level, the day before the procedure she had 9.11 mg.The patient stayed for at least 2 days in the critical care unit.The exchange fluid used was plasma.Patient id and age are not available at this time.The disposables set is not available for return because it was discarded by the customer.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure the patient showed signs of respiratory arrest after approximately one plasma volume exchanged.The patient presented with labial commissure lateralization previously manifested and treated with calcium gluconate and a rash treated with diphenhydramine.But the symptoms didn¿t disappear.The medical team also administrated hydrocortisone with no improvement, and finally they finished the procedure without blood devolution and with only one plasma volume exchanged.It was planned to be a 1.5 plasma volume exchanged.Per the customer, after resuscitation using amines, the patient had a low calcium level, the day before the procedure she had 9.11 mg.The patient stayed for at least 2 days in the critical care unit.The exchange fluid used was plasma.Patient id and age are not available at this time.The disposables set is not available for return because it was discarded by the customer.

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%.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.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.The product was not returned and therefore an evaluation could not be conducted.The customer indicated on the initial complaint form that the disposable set was unavailable as it had been discarded.The customer provided five photographs of the end of run summary screen in spanish language, one of which was duplicated.The photos confirmed the procedure was initiated at 10:11am with an ac flow rate of 3.0 ml/min at an infusion rate of 1.2 ml/min/l tbv with an inlet ac ratio of 13:1.The patient was disconnected at 12:26pm with a negative fluid balance of -108ml.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 definitive root cause for the patient's reaction could not be determined.Based on customer's statements about the reaction, possible causes for the allergic reaction include but are not limited to the patient's underlying disease state, an allergy to replacement solution and/or patient sensitivity to eto.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.Cause for the respiratory arrest is believed to be patient related.

• 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: 17003505
• MDR Text Key: 315942555
• Report Number: 1722028-2023-00188
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/25/2023

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 Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2208253130
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/25/2023
• Supplement Dates Manufacturer Received: 07/06/2023
• Supplement Dates FDA Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/31/2022
• 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): Required Intervention
• Patient Sex: Female
• Patient Weight: 56 KG