BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EARLY BIRD BLEED MONITORING SYSTEM

    MDR report key: 16441212 · Received February 26, 2023

    Report

    Report Number
    3016011241-2023-00002
    Event Type
    Injury
    Date Received
    February 26, 2023
    Date of Event
    June 7, 2021
    Report Date
    January 19, 2023
    Manufacturer
    SARANAS, INC.
    Product Code
    QFJ
    UDI-DI
    00866532000402
    PMA / PMN Number
    DEN180021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION AND DATA COLLECTED, IT WAS DETERMINED THAT THE EBBMS DID NOT CAUSE OR CONTRIBUTE TO DEATH, SERIOUS INJURY OR ILLNESS FOR THIS EVENT. THE EBBMS DEVICE FUNCTIONED AS INTENDED AS EVIDENCED BY THE PLOT OF THE IMPEDANCE SIGNAL. RELATED REPORT NUMBER: 3016011241-2022-00001.

    Description of Event or Problem · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1947401 EARLY BIRD BLEED MONITORING SYSTEM INTRAVASCULAR BLEED MONITOR QFJ SARANAS, INC. FG001-01 511110A 00866532000402

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention