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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problem Electrolyte Imbalance (2196)

Event Date 12/31/2010

Event Type  Injury  

Event Description

The journal article, 'how do we forecast tomorrows' transfusion: non-transfusional hemotherapy', a retrospective review between 2000 and 2010 was performed.The review analyzed 2,730 procedures performed in 317 patients.During that period, renal diseases represented the 62 % of the patients treated followed by hematological (16 %) and neurological (9 %) conditions.Adverse effects were noted in 3% of the procedures, mostly related to mild citrate-induced symptoms (34 % of them) and mild hemodynamic changes (31 %).Patient information and outcomes, as well as whether medical intervention was necessary, were not provided in the article, therefore this report is being filed as a summary of events.The collection sets are not available for return for evaluation.

Manufacturer Narrative

Lot number and expiry are not available at this time.Article citation: lozano, m.And cid, j.2023.How do we forecast tomorrows' transfusion: non-transfusional hemotherapy.Transfusion clinique et biologique., https://doi.Org/10.1016/j.Tracli.2023.01.007 investigation is in process.A follow up report will be provided.

• 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: 16537459
• MDR Text Key: 311225850
• Report Number: 1722028-2023-00101
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BK150251
• 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: 03/13/2023

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: 02/20/2023
• Initial Date FDA Received: 03/14/2023
• 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