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

Catalog Number 10220

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 03/31/2023

Event Type  Injury  

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: sumii, y., fujii, k., kondo, t., urata, t., kimura, m., fujiwara, h., asada, n., ennishi, d., nishimori, h., matsuoka, k., otsuka, f., maeda, y., & fujii, n.(2023).Evaluating the efficiency and safety of large-volume leukapheresis using the spectra optia continuous mononuclear cell collection protocol for peripheral blood stem cell collection from healthy donors: a retrospective study.Transfusion, 63(11), 2120¿2130.Https://doi.Org/10.1111/trf.17563.

Event Description

Per journal article "evaluating the efficiency and safety of large-volume leukapheresis using the spectra optia continuous mononuclear cell collection protocol for peripheral blood stem cell collection from healthy donors: a retrospective study " by yuichi sumii, keiko fujii, takumi kondo, tomohiro urata, maiko kimura, hideaki fujiwara, noboru asada, daisuke ennishi, hisakazu nishimori, ken-ichi matsuoka, fumio otsuka, yoshinobu maeda, nobuharu fujii" evaluating the efficiency and safety of large-volume leukapheresis using the spectra optia continuous mononuclear cell collection protocol for peripheral blood stem cell collection from healthy donors: a retrospective study.Although pre-apheresis cd34+ cell count was lesser in lvl (23.0 vs.58.0/¿l, p <.001), cd34+ collection efficiency was comparable between lvl and nvl (61.2% vs.61.4%, p =.966).Platelet loss was significantly higher in lvl compared to nvl (38.0% vs.29.4%, p <.001), with no correlation between attrition of platelet and processing blood volume.Moreover, the incidence of citrate toxicity during procedures was comparable between the two groups (31.6% vs.21.4%, p =.322).All lvl procedures could be completed without any adverse events.Both procedures were well tolerated by the donors, without any case of discontinuation.Plt loss and citrate toxicity, known as leukapheresis procedure-associated adverse events, were observed in both the groups.Although plt loss was significantly higher in the lvl group compared to the nvl group (38.0 ± 8.3% vs.29.4 ± 7.1%, p <.001), no bleeding episodes occurred and 18.4% of the lvl group were administered autologous plt-rich plasma infusion after leukapheresis (table 3).In lvl procedures, there was no correlation of pre-apheresis plt count (r =.0255, p =.879), pbv (r =.241, p =.144), and procedure time (r =.23, p =.164) with plt loss (figure 5).Clinical symptoms of hypocalcemia were restricted to mild appendicular.Collection from donors with a low number of cd34+ cells in peripheral blood using the popular apheresis system in daily clinical setting.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

• 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: 18791241
• MDR Text Key: 336362190
• Report Number: 1722028-2024-00066
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K183081
• 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: 02/27/2024

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 Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• 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): Required Intervention; Other