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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 10/31/2019

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: bougar, s.,atouf, o.,ouadghiri, s.,bourhanbour, a.D.,brick, c.,essakalli, m.Collection, cryopreservation and thawing of stem cells for children weighing less than 25 kg with high-risk neuroblastoma: a single center results in morocco.Hematology, transfusion, and cell therapy.2022; 44(4): 535-541.Investigation is in process.A follow up report will be provided.

Event Description

The journal article, 'collection, cryopreservation and thawing of stem cells for children weighing less than 25 kg with high-risk neuroblastoma: a single center results in morocco', describes a single institution¿s experience with cryopreservation of autologous peripheral blood stem cells (pbscs), using 10% dimethyl sulfoxide (dmso) and applying post-thaw dmso depletion.A total of 36 aphereses were performed on 29 children weighing less than 25 kg between july 2016 and october 2019.Four vasovagal effects were recorded related to leukapheresis, a mild and reversible decrease in blood pressure in one case at the end of the procedure, and a pulse rate over 120 bpm, only at the beginning of the leukapheresis.Patient information provided: seven females and twenty-two males, median bodyweight 14 kg (9 - 22).Individual patient information was not available in the article, therefore this report is being submitted as a summary of events.The leukapheresis sets are not available for return for evaluation.

Event Description

The journal article, 'collection, cryopreservation and thawing of stem cells for children weighing less than 25 kg with high-risk neuroblastoma: a single center results in morocco', describes a single institution¿s experience with cryopreservation of autologous peripheral blood stem cells (pbscs), using 10% dimethyl sulfoxide (dmso) and applying post-thaw dmso depletion.A total of 36 aphereses were performed on 29 children weighing less than 25 kg between (b)(6) 2016 and (b)(6) 2019.Four vasovagal effects were recorded related to leukapheresis, a mild and reversible decrease in blood pressure in one case at the end of the procedure, and a pulse rate over 120 bpm, only at the beginning of the leukapheresis.Patient information provided: seven females and twenty-two males, median bodyweight 14 kg (9 - 22).Individual patient information was not available in the article, therefore this report is being submitted as a summary of events.The leukapheresis sets are not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Lot number and expiry are not available at this time.Article citation: bougar, s.,atouf, o.,ouadghiri, s.,bourhanbour, a.D.,brick, c.,essakalli, m.Collection, cryopreservation and thawing of stem cells for children weighing less than 25 kg with high-risk neuroblastoma: a single center results in morocco.Hematology, transfusion, and cell therapy.2022; 44(4): 535-541.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.It was confirmed that the aes implicated in this article are not-reportable event.Only four vasovagal effects were recorded related to leukapheresis, a mild and reversible decrease in blood pressure in one case at the end of the procedure and a pulse rate over 120 bpm, only at the beginning of the leukapheresis.Neuroblastoma.Embryonal malignancy of the sympathetic nervous system.Autologous stem cell transplantation.No further reporting will be provided as this does not represent a reportable event.

• 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: 16034650
• MDR Text Key: 306013010
• Report Number: 1722028-2022-00419
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: MO
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/22/2022

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: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2022
• Initial Date FDA Received: 12/22/2022
• 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
• Patient Outcome(s): Other