Spectra Optia® 11300Recalls & reported problems
Terumo Bct, Inc. · BMP Accessory Set · Class 2
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 05020583113008), received between Jan 15, 2024 and Jan 15, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Device Handling Problem” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Device Handling Problem1
- Insufficient Device Problem Information1
- Use of Device Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionJan 15, 2024Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem; Use of Device Problem; Insufficient Device Problem Information; Device Handling Problem
THE CUSTOMER REPORTED TO TERUMO BCT CUSTOMER SUPPORT THAT AFTER A BONE MARROW PROCESSING (BMP) PROCEDURE WAS PERFORMED THEY FOUND VERY LOW RECOVERY. AFTER A FOLLOW-UP WITH THE CUSTOMER IT WAS NOTED THAT THE SET EXPIRED IN OCTOBER OF 2023. THE CUSTOMER STATED THAT THEY DID RE-STERILIZE THE SET FOR USE. PATIENT INFORMATION IS UNKNOWN AT THIS TIME. THERE WAS NO MEDICAL INTERVENTION REQUIRED FOR THIS EVENT. THE COLLECTION SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18510995 ↗
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.