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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Erythema (1840); Fever (1858); Rash (2033); Tachycardia (2095)

Event Date 08/25/2022

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.Citation: phou s, perez-alvarez i, morgan m, contreras da, ben-aderet m, gaddam e, et al.Successful autologous hematopoietic stem cell transplants using salmonella positive products collected from asymptomatic donors.Transfusion.2023;63(4): 861¿6.Https://doi.Org/10.1111/trf.17306.

Event Description

Per the journal article, "successful autologous hematopoietic stem cell transplants using salmonella positive products collected from asymptomatic donors." by phou, s.,perez-alvarez, et.Al."the patient tolerated the infusion well.On day 4 post-hsc infusion, she was started on levofloxacin as part of standard infectious disease prophylaxis which was switched to cefepime on day 6 given tachycardia to 110 bpm.On day 8, she began having ongoing fevers (peakat104°f)and cefepime was switched to meropenem.On day 10, she experienced diarrhea.On days 11, 12, she developed facial erythema, leg swelling, apetechial rash on the upper extremities, and a tachycardic episode to 170 bpm.Blood cultures collected on days 6, 8, and 12 were all negative.Given concern for engraftment syndrome, she was given solumedrol on days 12¿14 with transition to aprednisone taper.She improved clinically and was discharged on day 15.Neutrophil engraftment occurred on day 12 and platelet engraftment by day 25.On follow up day 85, she was doing well clinically." the collection set is not available for return because it was discarded by the customer.Specific details 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: 16935966
• MDR Text Key: 315271893
• Report Number: 1722028-2023-00181
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• 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: 04/20/2023
• 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
• Patient Age: 45 YR
• Patient Sex: Female