BEUDAMED
    FDA Adverse Event Summary report: N

    SORIN S5 BUBBLE DETECTOR

    MDR report key: 6029007 · Received October 13, 2016

    Report

    Report Number
    9611109-2016-00660
    Date Received
    October 13, 2016
    Date of Event
    September 16, 2016
    Report Date
    January 31, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE COMPLAINT INVESTIGATION, IT WAS DETERMINED THAT THIS IS NOT A REPORTABLE MALFUNCTION, AS THE FUNCTIONALITY OF THE DEVICE IS NOT AFFECTED. THE INITIAL REPORT, SUBMITTED ON (B)(6) 2016 CAN BE VOIDED. NO FURTHER FOLLOW-UPS WILL BE FILED FOR THIS EVENT.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN S5 BUBBLE DETECTOR. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR GAVE AN INCORRECT READING DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A REPLACEMENT BUBBLE SENSOR WAS PROVIDED TO THE CUSTOMER FOR INSTALLATION. FOLLOW-UP COMMUNICATION WITH THE CUSTOMER CONFIRMED THAT THE REPLACEMENT RESOLVED THE REPORTED ISSUE AND THE UNIT IS NOW FUNCTIONING AS EXPECTED. THE REPLACED DEVICE HAS BEEN REQUESTED FOR RETURN TO SORIN GROUP (B)(4) FOR INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR GAVE AN INCORRECT READING DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680093 SORIN S5 BUBBLE DETECTOR BUBBLE SENSOR TUBING 3/8 SORIN S5 SYSTEM KRL SORIN GROUP DEUTSCHLAND 23-07-50

    Patients

    Seq Age Sex Outcome Treatment
    1