Quantum® 21012Recalls & reported problems
Terumo Bct, Inc. · Quantum System Cell Expansion Set and Accessories, Cell Expansion Set · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 05020583210127), received between Dec 27, 2019 and Dec 27, 2019 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Contamination” (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.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Contamination1
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 27, 2019Adverse Event Without Identified Device or Use Problem; Contamination; Adverse Event Without Identified Device or Use Problem
THE CUSTOMER REPORTED CONTAMINATION INSIDE THE QUANTUM DISPOSABLES SET AFTER SEVERAL DAYS OF PROCESSING OF THE PRODUCT. PER THE CUSTOMER, THE SOURCE OF THE CONTAMINATION IS UNKNOWN, BUT MAY HAVE INTRODUCED BY THEM DURING NORMAL PROCESSING PROCEDURE. THE CUSTOMER PERFORMED TESTING ON ALL OF THE REAGENTS ATTACHED TO THE SETS, BUT ALL TESTS HAVE SHOWN THEM TO BE STERILE. IT IS UNKNOWN AT THIS TIME IF THE UNIT WAS TRANSFUSED. PATIENT INFORMATION AND OUTCOME ARE UNKNOWN AT THIS TIME. THE DISPOSABLE SET IS NOT AVAILABLE FOR RETURN BECAUSE IT WAS DISCARDED BY THE CUSTOMER.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9526183 ↗MalfunctionDec 27, 2019Adverse Event Without Identified Device or Use Problem; Contamination /Decontamination Problem; Adverse Event Without Identified Device or Use Problem
THERE WAS NOT A TRANSFUSION RECIPIENT OR PATIENT INVOLVED AT THE TIME OF THIS INCIDENT, THEREFORE NO PATIENT INFORMATION IS REASONABLY KNOWN AT THE TIME OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions; No Known Impact Or Consequence To Patient
MAUDE report 9526155 ↗
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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