Early Bird Bleed Monitoring System FG001-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00866532000402), received between Feb 26, 2023 and Feb 26, 2023 — classified as 1 death, 1 injury.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Aug 10, 2022Class IIOpen, Classified

   Bleed monitoring system device design error, causing the device to not power on and complete the series of self-tests so instructions for use being updated to include device check before use ensure that the device is functioning appropriately.

   Z-1684-2022 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

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

• InjuryFeb 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  A BLEED IN THE CONTRALATERAL RETROPERITONEAL SPACE DID NOT TRIGGER A LEVEL 1 BLEED INDICATION IN THE EARLY BIRD DEVICE. A PRODUCT EXPERIENCE REPORT WAS CREATED TO DOCUMENT THIS CASE AS AN INQUIRY ONLY BY THE INTERVENTIONIST. THE INTERVENTIONIST DID NOT INITIALLY PROVIDE ANY DATA REGARDING THE CASE OR PATIENT AS HIS INTEREST WAS IN THE BIOIMPEDANCE SIGNAL AS IT RELATED TO THIS CONTRALATERAL BLEED. THIS EVENT DID NOT TRIGGER A COMPLAINT; THE EARLY BIRD DEVICE IS NOT INTENDED TO DETECT CONTRALATERAL BLEEDS. WHILE INTERVENTION WAS REQUIRED AS A RESULT OF THE PROCEDURE, THE EARLY BIRD DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INJURY. THE PATIENT IS OK. AFTER MDR 3016011241-2022-00001 WAS SUBMITTED TO THE FDA DUE TO CUSTOMER FEEDBACK, AND AFTER DISCUSSIONS WITH PHYSICIANS AT THE SAME HOSPITAL, IT WAS DECIDED, OUT OF AN ABUNDANCE OF CAUTION, TO DOCUMENT THIS AS A RETROSPECTIVE MDR.

  Patient problems: Hematoma

  MAUDE report 16441212 ↗
• DeathFeb 26, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  DURING THE LARGE-BORE 16F SHEATH REMOVAL AND WIRE EXCHANGE, THE FIRST EARLY BIRD LEVEL 1 INDICATION WAS TRIGGERED. SHORTLY THEREAFTER, THE PATIENT'S PRESSURE DROPPED SIGNIFICANTLY, AND IT WAS DETERMINED AT THAT TIME THAT THE PATIENTS RIGHT COMMON ILIAC WAS PERFORATED. DR. (B)(6) AND STAFF BEGAN APPLYING PRESSURE WHILE THEY ASSESSED. DR. (B)(6) THEN PLACED 3 ATRIUM ILIAC COVERED STENTS TO REPAIR THE RIGHT COMMON ILIAC; THIS TOOK ROUGHLY 8-10 MINUTES. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE ILIAC STENT PLACEMENT AND ASSESS THE SITUATION. UNDER FURTHER EXAMINATION, IT WAS DETERMINED THAT THERE WAS ANOTHER PERFORATION NEAR THE AORTIC BIFURCATION. AN AORTIC OCCLUSION BALLOON (24 MM TRUE BALLOON) WAS PLACED IN THE ABDOMINAL AORTA TO TRY AND STOP THE BLEEDING. DURING THIS TIME, CPR AND CHEST COMPRESSIONS WERE BEING PERFORMED. ROUGHLY 18 MINUTES AFTER THE EARLY BIRD INDICATION, THE PATIENT HAD EXPIRED. THE EARLY BIRD WAS RETRIEVED AND SHIPPED BACK TO SARANAS FOR SIGNAL EXAMINATION. SARANAS CHIEF MEDICAL OFFICER THEN DISCUSSED THE BLEEDING SIGNAL WITH DR. (B)(6). PATIENT INFORMATION WAS NOT MADE AVAILABLE TO SARANAS FOR THIS EVENT.

  Patient problems: Low Blood Pressure/ Hypotension; Perforation of Vessels

  MAUDE report 16441207 ↗