Skip to content

KIDS D101 PHISIORecalls & reported problems

Sorin Group Italia Srl · Class 2

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 08033178109291), received between Sep 8, 2017 and Dec 30, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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

  • Fluid/Blood Leak1
  • Medical Gas Supply Problem1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1
  • No Consequences Or Impact To Patient1

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 30, 2021Medical Gas Supply Problem; Medical Gas Supply Problem

    SEE INITIAL REPORT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 13119535 ↗
  • MalfunctionSep 8, 2017Fluid/Blood Leak; Fluid/Blood Leak

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT BLOOD LEAKED FROM THE OXYGENATOR CHAMBER OF THE D101 KIDS INFANT HOLLOW FIBER MEMBRANE OXYGENATOR DURING A PROCEDURE. THE OXYGENATOR WAS CHANGED OUT AND THE PATIENT WAS GIVEN A BLOOD TRANSFUSION AS A RESULT. THERE WAS NO REPORT OF PATIENT INJURY.

    Patient problems: No Consequences Or Impact To Patient

    MAUDE report 6851026 ↗

Other OXYGENATOR, CARDIOPULMONARY BYPASS devices

All OXYGENATOR, CARDIOPULMONARY BYPASS devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.