KIDS D100 PHISIORecalls & reported problems
Sorin Group Italia Srl · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033178100359), received between Mar 14, 2017 and Dec 4, 2023 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Device Operational Issue1
- Low Readings1
- Medical Gas Supply Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2023Fluid/Blood Leak; Fluid/Blood Leak
SEE INITIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18254551 ↗MalfunctionDec 2, 2021Medical Gas Supply Problem; Medical Gas Supply Problem
SEE INTIAL REPORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12916320 ↗MalfunctionNov 23, 2017Fluid/Blood Leak; Fluid/Blood Leak
SORIN GROUP (B)(4) RECEIVED A REPORT THAT AFTER APPROX. 90 MIN OF THE CPB THE OPERATOR FOUND MASSIVE LEAK OF BLOOD FROM GAS OUTLET OF OXY MODULE. THE AFFECTED OXYGENATOR WAS REPLACED BY A NEW ONE WITHIN 8 MIN DURING CROSSCLAMP. THERE WAS NO REPORT OF PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7056671 ↗MalfunctionMar 14, 2017Low Readings; Device Operational Issue; Low Readings; Device Operational Issue
SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE ARTERIAL GAS (OXYGEN) LEVELS OF THE D 100 PH.I.S.I.O. OXYGENATOR DROPPED TO LOW VALUES DURING A PROCEDURE. THE PROCEDURE WAS COMPLETED WITHOUT CHANGING THE OXYGENATOR. THERE IS NO REPORT OF PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 6402817 ↗
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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 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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