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

Model Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2021

Event Type  Injury  

Event Description

The journal article, 'platelet decrease and efficacy of platelet-rich plasma return following peripheral blood stem cell apheresis' discusses platelet loss as a complication of peripheral blood stem cell (pbsc) transplants.The changes in platelet counts following pbsc-related apheresis in 270 allogeneic (allo)- and 105 autologous (auto)-pbsc settings were assessed.Per the article, "in both allo- and auto-pbsc settings, the preapheresis platelet count (range, 84-385 and 33-558 x10^9/l, respectively) decreased postapheresis (range, 57-292 and 20-429 x10^9/l, respectively), whereas severe platelet decrease (<50 x 10^9/l) was only observed in auto-pbsc patients (n = 9).We confirmed that platelet count before apheresis was a risk factor for severe platelet decrease (<50 x 10^9/l) following auto-pbsc apheresis.".

Manufacturer Narrative

Investigation: per the article, "allo-pbscs were collected by apheresis from healthy volunteer or related donors by using the spectra (n = 267) (terumo bct, tokyo, japan) or comtec (n = 3) (fresenius kabi, oberusel, germany) following granulocyte colony stimulation factor (g-csf) mobilization.Auto-pbscs were collected by apheresis from patients with hematologic malignancies in remission (n = 78), solid tumors (n = 18), and autoimmune diseases (n = 9) following chemotherapy and mobilization to gcsf by using the spectra (n = 105)." the article defines platelet loss severity as, "based on the common terminology criteria for adverse events (ctcae),13 normal/grade 1 (>75 x10^9/l), grade 2 (<75-50 x 10^9 /l), and grades 3-4 (<50 x 10^9/l) platelet counts following apheresis were defined as ¿normal platelets,¿ ¿mild platelet reduction,¿ and ¿severe platelet reduction,¿ respectively, in this study." "none of the allo-pbsc donors experienced severe platelet reduction following apheresis.Among the auto-pbsc patients, 73 had normal platelets, 23 had mild platelet reduction, and 9 (8 of grade 3 patients and 1 of grade 4 patient) had severe (<50 x 10^9/l) platelet reduction." article citation: shima, t., et al.2020.Platelet decrease and efficacy of platelet-rich plasma return following peripheral blood stem cell apheresis.Journal of clinical apheresis.36:687-696.Doi: 10.1002/jca.21917 investigation is in process.A follow up report will be filed.

Manufacturer Narrative

This report is being filed to provide additional information in g.4, h.6 and h.10.Corrected information is provided in d.2 and d.4.Investigation: per the article, "allo-pbscs were collected by apheresis from healthy volunteer or related donors by using the spectra (n = 267) (terumo bct, tokyo, japan) or comtec (n = 3) (fresenius kabi, oberusel, germany) following granulocyte colony stimulation factor (g-csf) mobilization.Auto-pbscs were collected by apheresis from patients with hematologic malignancies in remission (n = 78), solid tumors (n = 18), and autoimmune diseases (n = 9) following chemotherapy and mobilization to gcsf by using the spectra (n = 105)." the article defines platelet loss severity as, "based on the common terminology criteria for adverse events (ctcae),13 normal/grade 1 (>75 x10^9/l), grade 2 (<75-50 x 10^9 /l), and grades 3-4 (<50 x 10^9/l) platelet counts following apheresis were defined as ¿normal platelets,¿ ¿mild platelet reduction,¿ and ¿severe platelet reduction,¿ respectively, in this study." "none of the allo-pbsc donors experienced severe platelet reduction following apheresis.Among the auto-pbsc patients, 73 had normal platelets, 23 had mild platelet reduction, and 9 (8 of grade 3 patients and 1 of grade 4 patient) had severe (<50 x 10^9/l) platelet reduction." article citation: shima, t., et al.2020.Platelet decrease and efficacy of platelet-rich plasma return following peripheral blood stem cell apheresis.Journal of clinical apheresis.36:687-696.Doi: 10.1002/jca.21917.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 authors reported severe platelet decreases in 9 patients who required transfusion of their autologous platelet rich plasma prepared from the collected stem cell products.Although platelet transfusion is considered a medical intervention, the authors also stated that ¿prp return following pbsc apheresis has been generally performed in our institution regardless of platelet counts at preapheresis or postapheresis.¿.This is part of planned protocol.No further reporting will be provided as this does not represent a reportable event.

Event Description

The journal article, 'platelet decrease and efficacy of platelet-rich plasma return following peripheral blood stem cell apheresis' discusses platelet loss as a complication of peripheral blood stem cell (pbsc) transplants.The changes in platelet counts following pbsc-related apheresis in 270 allogeneic (allo)- and 105 autologous (auto)-pbsc settings were assessed.Per the article, "in both allo- and auto-pbsc settings, the preapheresis platelet count (range, 84-385 and 33-558 x10^9/l, respectively) decreased postapheresis (range, 57-292 and 20-429 x10^9/l, respectively), whereas severe platelet decrease (<50 x 10^9/l) was only observed in auto-pbsc patients (n = 9).We confirmed that platelet count before apheresis was a risk factor for severe platelet decrease (<50 x 10^9/l) following auto-pbsc apheresis.".

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 14119129
• MDR Text Key: 290545917
• Report Number: 1722028-2022-00126
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2022

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: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 05/18/2022
• Supplement Dates FDA Received: 06/01/2022
• 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