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

Catalog Number 10220

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/07/2024

Event Type  Injury  

Event Description

Per journal article "the implementation of automated red blood cell exchange (erythrocytapheresis) as a treatment modality in sickle cell disease patients: single center experience" by fatma soliman elsayed ebeid improvements of health infrastructure, preventive care and clinical management is important to reduce the morbidity and mortality of sickle cell disease (scd).Objective: this prospective, investigator-initiated non-randomized open-label intervention, single centre study describes the implementation of the automated erythrocytapheresis in low-middle income country as a treatment modality for scd patients to improve the standard of care and highlights its benefits and challenges.Methodology: eligible patients with scd who had overt stroke, abnormal/conditional transcranial doppler (tcd), or other indications were subjected to regular automated erythrocytapheresis program.Results: from 18th dec 2017 till 17th dec 2022, 21 subjects were enrolled; seventeen (80.9 %) were egyptian and four (19.1 %) were non-egyptian (three sudanese and one nigerian).Totalling 133 sessions had been performed mainly in working hours with fluctuating frequency per month.All sessions maintained isovolumic status and were performed using central venous access.The target hbs concentration was set from the start; the mean final fcr % fraction was 51, most of the session (n = 78, 58.7 %) were able to achieve target fcr.The majority of session pass smoothly with no adverse event (n = 81, 60.9 %), except for certain challenges as shortage of the required blood (n = 38), hypotension (n = 2), hypocalcaemia (n = 2).Conclusion: automated erythrocytapheresis is safe and effective modality for management of patients with sickle cell disease.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.

Manufacturer Narrative

Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Citation: ebeid, f.S.E.(2023).The implementation of automated red blood cell exchange (erythrocytapheresis) as a treatment modality in sickle cell disease patients: single center experience.Transfusion and apheresis science, 62(4), 103719.Https://doi.Org/10.1016/j.Transci.2023.103719.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Citation: ebeid, f.S.E.(2023).The implementation of automated red blood cell exchange (erythrocytapheresis) as a treatment modality in sickle cell disease patients: single center experience.Transfusion and apheresis science, 62(4), 103719.Https://doi.Org/10.1016/j.Transci.2023.103719 further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.No further reporting will be provided as this does not represent a reportable event.

Event Description

Per journal article "the implementation of automated red blood cell exchange (erythrocytapheresis) as a treatment modality in sickle cell disease patients: single center experience" by fatma soliman elsayed ebeid improvements of health infrastructure, preventive care and clinical management is important to reduce the morbidity and mortality of sickle cell disease (scd).Objective: this prospective, investigator-initiated non-randomized open-label intervention, single centre study describes the implementation of the automated erythrocytapheresis in low-middle income country as a treatment modality for scd patients to improve the standard of care and highlights its benefits and challenges.Methodology: eligible patients with scd who had overt stroke, abnormal/conditional transcranial doppler (tcd), or other indications were subjected to regular automated erythrocytapheresis program.Results: from (b)(6) 2017 till (b)(6) 2022, 21 subjects were enrolled; seventeen (80.9 %) were egyptian and four (19.1 %) were non-egyptian (three sudanese and one nigerian).Totalling 133 sessions had been performed mainly in working hours with fluctuating frequency per month.All sessions maintained isovolumic status and were performed using central venous access.The target hbs concentration was set from the start; the mean final fcr % fraction was 51, most of the session (n = 78, 58.7 %) were able to achieve target fcr.The majority of session pass smoothly with no adverse event (n = 81, 60.9 %), except for certain challenges as shortage of the required blood (n = 38), hypotension (n = 2), hypocalcaemia (n = 2).Conclusion: automated erythrocytapheresis is safe and effective modality for management of patients with sickle cell disease.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.It is unknown at this time if medical intervention was required for these events.

• 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: 18857998
• MDR Text Key: 337184253
• Report Number: 1722028-2024-00074
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2024
• 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