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

Model Number 10310

Device Problem Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Electrolyte Imbalance (2196)

Event Date 03/18/2022

Event Type  Injury  

Event Description

The journal article, 'a comparison of four leukapheresis methods to harvest an optimal dose of cd34+ cells: a single center experience', a retrospective study analyzed data for patients 18 years and older with hematologic malignancies (multiple myeloma (mm), hodgkin's lymphoma and non-hodgkin's lymphoma (nhl)) undergoing autologous stem cell transplantation (asct).116 patients (78 with mm and 38 with nhl) were included in the study group and 34 patients (25 with mm and 9 with nhl) served as the control group.Leukaphereses were performed using the spectra apheresis device.The leukapheresis methods used included high volume (hv) leukapheresis versus regular volume (rv) with or without antagonist plerixafor (px).Among all hspc mobilization and collection procedures, in 4.4% of all collections, patients experienced some degree of numbness and/or tingling of fingers, toes or lips, which were readily resolved with calcium replacement (orally or intravenously).Overall, hv leukapheresis group experienced relatively more adverse effects compared to rv leukapheresis, most of which were hypotension and dizziness (5% vs.1.9%), packed red blood cell transfusion (5% vs.3.8%) and platelet transfusion (22.5% vs.3.8%).On the other hand, rv versus hv leukapheresis in combination with px resulted in more electrolyte disturbance requiring electrolyte (potassium or magnesium or both) replacement (25.7% vs.12.5%) than hv.Individual patient information is not provided 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

Lot number and expiry are not available at this time.Article citation: lin y, park y, khanal a, et al.A comparison of four leukapheresis methods to harvest an optimal dose of cd34+ cells: a single center experience.European journal of haematology.2022;109(6):711-718.Doi:10.1111/ejh.13856 investigation is in process.A follow up report will be provided.

• 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: 16017864
• MDR Text Key: 305842149
• Report Number: 1722028-2022-00414
• 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: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/20/2022

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: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2022
• Initial Date FDA Received: 12/20/2022
• 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