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

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 11/17/2021

Event Type  Injury  

Manufacturer Narrative

Device lot number and expiry are not available at this time.Investigation: per the article, "all patients planned for asct followed the gsh haematology unit protocol for the mobilisation and collection of pbscs.Donors received etoposide 1000mg/m2 iv for two consecutive days (day 1 and 2 of the protocol) in the outpatient department.G-csf was commenced at 10ug/kg daily subcutaneously from day 5 up to day 15; a split dose regimen of 300ug twice daily (300ug filgrastim vials were used).Patients would be followed up on days 9 and 11 to check their blood counts and renal function, assess the patient clinically and to ensure compliance with g-csf administration.On day 14 and 15 a pbcd34 count was obtained to assess the likelihood of a successful cd34 collection.Patients with a pbcd34 < 10 cells/ul were continued on g-csf for up to four days depending on the pbcd34 and wcc response.If the pbcd34 reached a plateau despite ongoing g-csf administration, apheresis was abandoned.Apheresis was performed utilising a continuous flow apheresis system (spectra optia, terumo bct) through a percutaneous femoral venous catheter." article citation: justin du toit, marco goeijenbier, cecile du toit, pieter de witt, hannes koornhof, jenna oosthuizen, vernon johan louw, matthew seftel and estelle verburgh, predictors of poor haematopoietic stem cell mobilisation in patients with haematological malignancies at a south african centre, transfusion and apheresis science, (2021).Doi:https://doi.Org/10.1016/j.Transci.2022.103419.Investigation is in process.A follow-up report will be provided.

Event Description

The journal article, 'predictors of poor haematopoietic stem cell mobilisation in patients with haematological malignancies at a south african centre' discusses a retrospective study of patients with haematological malignancies that consecutively underwent autologous stem cell transplant (asct) at a center.In the study, the patient sample includes: 146 patients ¿ majority with multiple myeloma (mm)(41,8%), f:m=1:2, underwent leukapheresis with median age of 32 years (range, 9 ¿ 66 years).Poor mobilization(pm) occurred in 25/146 (17%), mobilisation failure (mf) in 3/146 (2%) and super mobilisation (sms) in 99/146 (68%), respectively.Risk factors for pm were: diagnosis of acute leukaemia (rr=25, 95% ci 3.4 ¿ 183, p=0.002) and hodgkin lymphoma (rr=19, 95% ci 2.6 ¿ 142, p=0.004); low white cell count (wcc) at harvest (wcc < 9 x 109/l (rr=4.3, 95% ci 2.3 ¿ 8.3, p <0.0001) and two vs one line of prior therapy (rr=3.1, 95% ci 1.45 ¿ 6.7, p=0.0037).Exact details of events, any necessary medical intervention, or further patient information is not provided in the article, therefore this report is being filed as a summary.The device is not available for return and evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Device lot number and expiry are not available at this time.Investigation: per the article, "all patients planned for asct followed the gsh haematology unit protocol for the mobilisation and collection of pbscs.Donors received etoposide 1000mg/m2 iv for two consecutive days (day 1 and 2 of the protocol) in the outpatient department.G-csf was commenced at 10ug/kg daily subcutaneously from day 5 up to day 15; a split dose regimen of 300ug twice daily (300ug filgrastim vials were used).Patients would be followed up on days 9 and 11 to check their blood counts and renal function, assess the patient clinically and to ensure compliance with g-csf administration.On day 14 and 15 a pbcd34 count was obtained to assess the likelihood of a successful cd34 collection.Patients with a pbcd34 < 10 cells/ul were continued on g-csf for up to four days depending on the pbcd34 and wcc response.If the pbcd34 reached a plateau despite ongoing g-csf administration, apheresis was abandoned.Apheresis was performed utilising a continuous flow apheresis system (spectra optia, terumo bct) through a percutaneous femoral venous catheter." article citation: justin du toit, marco goeijenbier, cecile du toit, pieter de witt, hannes koornhof, jenna oosthuizen, vernon johan louw, matthew seftel and estelle verburgh, predictors of poor haematopoietic stem cell mobilisation in patients with haematological malignancies at a south african centre, transfusion and apheresis science, (2021) doi:https://doi.Org/10.1016/j.Transci.2022.103419.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 this is a study that evaluated the gcsf mobilization impact on the stem cell harvest failures.The adverse events reported were related to the mobilization regimen and not caused by spectra optia.Three patients failed to collect enough stem cells for engraftment due to poor mobilization and represents poor yield.No further reporting will be provided as this does not represent a reportable event.

Event Description

The journal article, 'predictors of poor haematopoietic stem cell mobilisation in patients with haematological malignancies at a south african centre' discusses a retrospective study of patients with haematological malignancies that consecutively underwent autologous stem cell transplant (asct) at a center.In the study, the patient sample includes: 146 patients ¿ majority with multiple myeloma (mm)(41,8%), f:m=1:2, underwent leukapheresis with median age of 32 years (range, 9 ¿ 66 years).Poor mobilization(pm) occurred in 25/146 (17%), mobilisation failure (mf) in 3/146 (2%) and super mobilisation (sms) in 99/146 (68%), respectively.Risk factors for pm were: diagnosis of acute leukaemia (rr=25, 95% ci 3.4 ¿ 183, p=0.002) and hodgkin lymphoma (rr=19, 95% ci 2.6 ¿ 142, p=0.004); low white cell count (wcc) at harvest (wcc < 9 x 109/l (rr=4.3, 95% ci 2.3 ¿ 8.3, p <0.0001) and two vs one line of prior therapy (rr=3.1, 95% ci 1.45 ¿ 6.7, p=0.0037).Exact details of events, any necessary medical intervention, or further patient information is not provided in the article, therefore this report is being filed as a summary.The device is not available for return and evaluation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET,EA
• 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: 14119204
• MDR Text Key: 289358118
• Report Number: 1722028-2022-00127
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,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: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• 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