BEUDAMED
    FDA Adverse Event Summary report: N

    SORIN S3 BUBB DET SENSOR, LOW LEVEL II

    MDR report key: 5112571 · Received September 30, 2015

    Report

    Report Number
    9611109-2015-00386
    Date Received
    September 30, 2015
    Date of Event
    September 1, 2015
    Report Date
    September 1, 2015
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBB DET SENSOR, LOW LEVEL II. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT AN S5 BUBBLE SENSOR WAS NOT DETECTING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT. THE INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN S3 BUBB DET SENSOR, LOW LEVEL II. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF SORIN GROUP (B)(4). SORIN GROUP RECEIVED A REPORT THAT AN S5 BUBBLE SENSOR WAS NOT DETECTING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT. THE BUBBLE SENSOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. VISUAL INSPECTION DID NOT IDENTIFY ANY ABNORMALITIES OR DEFECTS. FUNCTIONAL TESTING AND A HARDWARE ANALYSIS COULD NOT REPRODUCE THE REPORTED ISSUE. ONE MEASUREMENT WAS FOUND TO BE SLIGHTLY OUT OF TOLERANCE DURING ANALYSIS, HOWEVER THIS MEASUREMENT IS UNRELATED TO THE REPORTED ISSUE. THE RETURNED SENSOR WAS SCRAPPED UPON COMPLETION OF THE EVALUATION. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. SORIN GROUP (B)(4) WILL CONTINUE TO MONITOR FOR TRENDS RELATED TO THIS TYPE OF ISSUE.

    Description of Event or Problem · 1

    SORIN GROUP RECEIVED A REPORT THAT AN S5 BUBBLE SENSOR WAS NOT DETECTING BUBBLES. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    645872 SORIN S3 BUBB DET SENSOR, LOW LEVEL II MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS KRL SORIN GROUP DEUTSCHLAND 23-07-50 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 0 YR