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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problems Hearing Impairment (1881); Dizziness (2194); Malaise (2359); Paresthesia (4421)

Event Date 03/19/2023

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process.A follow-up report will be provided.Article citation: ayumi kamo-imai, tomiteru togano, motohiko sato, yuiko kawakami, kumi inaba, hiroshi shimazu, saori igarashi, keiko tanaka, mari terada, noriko kinoshita-iwamoto, sho saito, satoshi kutsuna, akira hangaishi, shinichiro morioka, kenzo takahashi, satoshi miyata and norio ohmagari, the safety of plasma apheresis from donors recovering from covid19 infection in japan, transfusion and apheresis science, (2023) doi:https://doi.Org/10.1016/j.Transci.2023.103687.

Event Description

Per the journal article: the safety of plasma apheresis from donors recovering from covid-19 infection in japan.Transfusion and apheresis science.2023.By kamo-imai, ayumi, togano, tomiteru,sato, motohiko,kawakami, et al."we used two types of apheresis machines: 48 donors used the spectra optia (17.7%) and 125 donors used the com.Tec (72.3%).The frequency of daes was higher in the spectra optia group, though insignificant.The number of grade 2 daes was significantly higher in the spectra optia group than in the com.Tec group.There were 12 adverse reactions, four occurred during and eight after apheresis.Half of the daes were vasovagal reactions (vvr) with or without a decrease in blood pressure during apheresis.Vvr was also seen in three cases after apheresis.Although three of six donors with vvr needed an infusion of saline, all participants rapidly recovered.The other cases of daes were grade 1 sscrbd [11] and ctcae 5.0 [13] criteria, except for three replenishment cases.Mild daes were paresthesia during apheresis, two incidences of malaise, and one each of agitation, dizziness, and hearing impairment/paresthesia after apheresis.All the daes improved within hours from onset." per the article, three of the six vasovagal reactions required an infusion of saline.All other adverse events improved within hours of onset.All patients were listed as improved at the end of the study.The collection set is not available for return because it was discarded by the customer.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.

• 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: 16808260
• MDR Text Key: 313937370
• Report Number: 1722028-2023-00156
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• 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: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2023
• 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
• Date Manufacturer Received: 03/31/2023
• 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