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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problems Diarrhea (1811); Fever (1858)

Event Date 08/26/2022

Event Type  Injury  

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 8 post-hsc infusion, she developed a fever to 100.7°f and on day 9 experienced non-bloody diarrhea with escherichia coli bacteremia.She was treated with cefepime (3-day course) which was switched to ceftriaxone (10-day course) prior to discharge and did well clinically without additional symptoms.Neutrophil engraftment occurred on day 11 and platelet engraftment occurred by day 20.She was discharged on day 12 and was doing well on follow-up on day 83." 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.

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.

• 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: 16931107
• MDR Text Key: 315209857
• Report Number: 1722028-2023-00180
• 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

• 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: 04/20/2023
• Initial Date FDA Received: 05/15/2023
• 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: 66 YR
• Patient Sex: Female