LILLIPUT D902 PH.I.S.I.O.Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 08033178100397), received between Nov 8, 2017 and May 2, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 2, 2024Unexpected Therapeutic Results; Unexpected Therapeutic Results

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT, DURING A PEDIATRIC CARDIAC SURGERY, AFTER FEW MINUTES OF CARDIAC BYPASS INITIATION, IT WAS FOUND THAT THE P02 LEVELS BLOOD GAS WERE 90MMHG WITH FI02 100%. MEDICAL TEAM REPEAT SAMPLE AND SHOWED 99MMHG. MEDICAL TEAM EVALUATED THE VALUE NOT ACCEPTABLE AND ELECTED TO CHANGE OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19228063 ↗
• MalfunctionMay 25, 2023Disconnection; Fluid/Blood Leak; Disconnection; Fluid/Blood Leak

  SORIN GROUP ITALIA HAS RECEIVED A REPORT THAT OF A LEAKAGE AT THE LILLIPUT OXYGENATOR ARTERIAL OUTLET DURING A PROCEDURE. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17002167 ↗
• MalfunctionJan 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT, 4 LILLIPUT OXYGENATORS LEAKED FROM OXY SITE WHEN CONNECTED TO THE HEATER COOLER (1 UNIT LOT 2002260217 AND 3 UNITS LOT 2002260216). DURING FOLLOW UP WITH THE CUSTOMER, SORIN GROUP (B)(4) HAS RECEIVED THAT DID NOT CLARIFY IF WATER ENTERED THE RESERVOIR WHEN PRIMING THE WATER SIDE OF LILLIPUT OXYGENATORS. THE EVENTS OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266472 ↗
• MalfunctionJan 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  SORIN GROUP (B)(4) RECEIVED A REPORT THAT, 4 LILLIPUT OXYGENATORS LEAKED FROM OXY SITE WHEN CONNECTED TO THE HEATER COOLER (1 UNIT LOT 2002260217 AND 3 UNITS LOT 2002260216). DURING FOLLOW UP WITH THE CUSTOMER, SORIN GROUP (B)(4) HAS RECEIVED THAT DID NOT CLARIFY IF WATER ENTERED THE RESERVOIR WHEN PRIMING THE WATER SIDE OF LILLIPUT OXYGENATORS. THE EVENTS OCCURRED PRIOR TO ANY PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13266465 ↗
• MalfunctionNov 24, 2021Blocked Connection; Blocked Connection

  SEE INITIAL REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12867993 ↗
• MalfunctionSep 15, 2021Medical Gas Supply Problem; Medical Gas Supply Problem

  SORIN GROUP (B)(4) HAS RECEIVED A REPORT THAT, DURING A PROCEDURE, THE D902 DIDECO LILLIPUT PHISIO OXYGENATOR WAS NOT OXYGENATING AS EXPECTED. MEDICAL TEAM ELECTED TO CHANGE-OUT THE OXYGENATOR. THERE IS NO REPORT OF ANY PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12475310 ↗
• MalfunctionNov 8, 2017Air Leak; Air Leak

  SORIN GROUP (B)(6) RECEIVED A REPORT THAT AN ESCAPE OF AIR WAS OBSERVED FROM THE D902 LILLIPUT OXYGENATOR DURING A PROCEDURE AND A LARGE AMOUNT OF FOAM WAS NOTICED. THE AIR REPORTEDLY ESCAPED THROUGH THE UPPER RIGHT SIDE OF THE RESERVOIR FILTER. THE PATIENT REQUIRED TRANSFUSION THERAPY OF ALL FACTORS. THE PATIENT REPORTEDLY SUFFERED FROM CONSUMPTION COAGULOPATHY.

  Patient problems: Coagulation Disorder

  MAUDE report 7008906 ↗