BEUDAMED
    FDA Adverse Event Summary report: N

    SORIN S5 BUBBLE DETECTOR

    MDR report key: 6012744 · Received October 7, 2016

    Report

    Report Number
    9611109-2016-00632
    Date Received
    October 7, 2016
    Date of Event
    September 7, 2016
    Report Date
    March 24, 2017
    Manufacturer
    SORIN GROUP DEUTSCHLAND
    Product Code
    KRL
    PMA / PMN Number
    K955152
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SORIN GROUP (B)(4) MANUFACTURES THE SORIN CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(4). 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 CUSHIONS WERE FOUND TO BE DEFLATED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY. A SORIN GROUP FIELD SERVICE REPRESENTATIVE WAS DISPATCHED THE FACILITY TO INVESTIGATE. THE SERVICE REPRESENTATIVE WAS UNABLE TO IDENTIFY THE ISSUE ON SITE. THE BUBBLE SENSOR WAS RETURNED TO SORIN GROUP (B)(4) FOR FURTHER INVESTIGATION. THE INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SENT WHEN THE INVESTIGATION IS COMPLETE. EVALUATION IN PROGRESS.

    Additional Manufacturer Narrative · 1

    LIVANOVA (B)(4) MANUFACTURES THE CENTRIFUGAL PUMP SYSTEM. THE INCIDENT OCCURRED IN (B)(6). THIS MEDWATCH REPORT IS BEING FILED ON BEHALF OF LIVANOVA (B)(4). THE BUBBLE SENSOR WAS RETURNED TO LIVANOVA (B)(4) FOR EVALUATION. DETAILED INSPECTION IDENTIFIED A TEAR IN THE RIGHT SIDE PILLOW AND THE GEL HAD LEAKED OUT. THE SPECIFIC CAUSE OF THE TEAR CANNOT BE DETERMINED AS IT OCCURRED DURING USE BY THE CUSTOMER. A REVIEW OF THE DHR DID NOT IDENTIFY ANY DEVIATIONS OR NON-CONFORMITIES RELEVANT TO THE REPORTED ISSUE. A TREND OF FAILING BUBBLE SENSORS DUE TO LEAKS IN CUSHIONS HAS NOT BEEN IDENTIFIED SO FAR. HOWEVER, CAPA (B)(4) WAS INITIATED TO EVALUATE THE LIFETIME OF THE BUBBLE SENSOR.

    Description of Event or Problem · 1

    SORIN GROUP (B)(4) RECEIVED A REPORT THAT THE SORIN S5 BUBBLE DETECTOR CUSHIONS WERE FOUND TO BE DEFLATED DURING A PROCEDURE. THERE WAS NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    663345 SORIN S5 BUBBLE DETECTOR DETECTOR, BUBBLE, CARDIOPULMONARY BYPASS KRL SORIN GROUP DEUTSCHLAND 23-07-50

    Patients

    Seq Age Sex Outcome Treatment
    1