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 Chest Pain (1776); Low Blood Pressure/ Hypotension (1914)

Event Date 10/17/2022

Event Type  Injury  

Manufacturer Narrative

Investigation: per the customer, the patient received lotensin 10/12.5mg po @ 9:19 am.The procedure started at 11:14 am.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that a patient's blood pressure (bp) dropped during a therapeutic plasma exchange procedure.Three minutes after starting the procedure, the patient's bp dropped to 85/42.The provider ordered a 300ml normal saline bolus iv and to lower the inlet flow rate.After 3 minutes, the bp dropped again to 81/46 and the patient was taken off the machine.After taking the patient off, the physician ordered the patient to receive a loading dose of albumin 25 gm iv and to restart the procedure with a lowered inlet flow rate between 30-60 ml/min.Before the procedure was restarted, the bp was 123/61.After 30 min the patient complained of pressure on the chest and chest pain.Rinseback was performed.The physician ordered a stat ekg and to discontinue the procedure.The patient is now in stable condition.The exchange set is not available for return for evaluation.

Event Description

The customer reported that a patient's blood pressure (bp) dropped during a therapeutic plasma exchange procedure.Three minutes after starting the procedure, the patient's bp dropped to 85/42.The provider ordered a 300ml normal saline bolus iv and to lower the inlet flow rate.After 3 minutes, the bp dropped again to 81/46 and the patient was taken off the machine.After taking the patient off, the physician ordered the patient to receive a loading dose of albumin 25 gm iv and to restart the procedure with a lowered inlet flow rate between 30-60 ml/min.Before the procedure was restarted, the bp was 123/61.After 30 min the patient complained of pressure on the chest and chest pain.Rinseback was performed.The physician ordered a stat ekg and to discontinue the procedure.The patient is now in stable condition.The exchange set is not available for return for evaluation.

Manufacturer Narrative

Investigation: per the customer, the patient received lotensin 10/12.5mg po @ 9:19 am.The procedure started at 11:14 am.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.The run data file (rdf) was analyzed for this event.In total, 2 rdfs were reviewed for this analysis from october 17th.No definitive root cause for the reported adverse patient reactions could be identified from the rdfs associated with this procedure.Review of the run data files for the 2 attempted therapeutic plasma exchange (tpe) procedures did not indicate a root cause for the reported 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 rdf that would indicate any issues in the run related to the patient pressure drop.The commanded pump speeds and the measured pump speeds were accurate and did not show any discrepancy in pump volume.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.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.Root cause: a root cause assessment was performed for this complaint.The reported hypotension is a common side effect of therapeutic apheresis procedures.It is typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per the customer, the patient received lotensin 10/12.5mg po @ 9:19 am.The procedure started at 11:14 am.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.The run data file (rdf) was analyzed for this event.In total, 2 rdfs were reviewed for this analysis from (b)(6) 2022.No definitive root cause for the reported adverse patient reactions could be identified from the rdfs associated with this procedure.Review of the run data files for the 2 attempted therapeutic plasma exchange (tpe) procedures did not indicate a root cause for the reported 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 rdf that would indicate any issues in the run related to the patient pressure drop.The commanded pump speeds and the measured pump speeds were accurate and did not show any discrepancy in pump volume.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that a patient's blood pressure (bp) dropped during a therapeutic plasma exchange procedure.Three minutes after starting the procedure, the patient's bp dropped to 85/42.The provider ordered a 300ml normal saline bolus iv and to lower the inlet flow rate.After 3 minutes, the bp dropped again to 81/46 and the patient was taken off the machine.After taking the patient off, the physician ordered the patient to receive a loading dose of albumin 25 gm iv and to restart the procedure with a lowered inlet flow rate between 30-60 ml/min.Before the procedure was restarted, the bp was 123/61.After 30 min the patient complained of pressure on the chest and chest pain.Rinseback was performed.The physician ordered a stat ekg and to discontinue the procedure.The patient is now in stable condition.The exchange set is not available for return for evaluation.

• 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: 15774091
• MDR Text Key: 303548074
• Report Number: 1722028-2022-00360
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 11/10/2022

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: 4122201
• Device Lot Number: 2208266141
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 11/30/2022; 12/13/2022
• Supplement Dates FDA Received: 12/05/2022; 12/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/26/2022
• 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 Age: 51 YR
• Patient Sex: Female
• Patient Weight: 126 KG