HemoSphere Tissue Oximetry Module HEMTOM10Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00690103200355), received between Jun 30, 2022 and Feb 12, 2025 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (3 reports).

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

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 12, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT A HEMTOM10 HAD INTERMITTENT CONNECTION WHICH CAUSED INCONSISTENT VALUES. DURING A CASE, STAFF NOTICED THE VALUE DECREASE. IT IS UNKNOWN WHICH HEMODYNAMIC VALUE DECREASED. THE ISSUE WAS RESOLVED BY EXCHANGING THE MODULE. THERE WERE NO PATIENT INJURIES. THE DEVICE IS AVAILABLE FOR RETURN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21370434 ↗
• MalfunctionAug 3, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMTOM10 HAS BEEN GENERATING INTERMITTENT AND FLUCTUATING STO2 VALUES. THE ISSUE HAS BEEN WITH THE A1 L VALUES. THE A2 R VALUE STAYED STEADY FROM 88 89 DURING A CASE. WHEN THERE IS A VALUE THE A1 L VALUE FLUCTUATED BETWEEN 65 TO 88 CHANGING EVERY FEW SECONDS. AFTER A FEW MINUTES OF DISPLAYED VALUES THE A1 L SUDDENLY STOPS GENERATING VALUES. AFTER SEVERAL MINUTES THE CYCLE STARTS AGAIN. THIS WAS DURING USE. THERE IS NO PATIENT INJURY. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE. A HEM1 HEMFSM10 AND FORESIGHT SENSOR WILL ALSO BE SENT IN SEPARATE MDRS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161315 ↗
• MalfunctionJun 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT THE HEMFSM10 CHANNEL 2 STO2 VALUE DROPPED 15 TO 20 POINTS AFTER STARTING A NEW PATIENT IN HEMOSPHERE. THEY STARTED THE CASE WITH FORESIGHT ONLY AND THE INITIAL STO2 VALUES FOR BOTH LEFT AND RIGHT BRAIN WERE IN THE MID 70S. THE ATTENDING ANESTHESIOLOGIST DECIDED TO CONNECT THE SWAN GANZ. THEY TURNED THE HEMOSPHERE OFF AND STARTED A NEW PATIENT. ONCE THE HEMOSPHERE CAME UP AGAIN THE LEFT STO2 CHANNEL 1 VALUES WERE THE SAME 72 TO 74 BUT THE RIGHT STO2 CHANNEL 2 DROPPED 15 TO 20 POINTS. THE DIFFERENCE REMAINED THE ENTIRE CASE. THIS WAS DURING USE. THERE IS NO PATIENT INJURY. THERE WILL BE NO PRODUCT RETURN PER THE REP. PATIENT DEMOGRAPHICS WERE REQUESTED BUT UNAVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14879625 ↗