BEUDAMED
    FDA Adverse Event Death Summary report: N

    VARIO18 AC/DC,100-240V,PT-C

    MDR report key: 16585740 · Received March 21, 2023

    Report

    Report Number
    3002807523-2023-00003
    Event Type
    Death
    Date Received
    March 21, 2023
    Date of Event
    March 15, 2023
    Report Date
    June 13, 2023
    Manufacturer
    MEDELA AG
    Product Code
    BTA
    UDI-DI
    07612367016056
    PMA / PMN Number
    K153663
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE OFFICIAL MEDELA REPRESENTATIVE VISITED THE MEDICAL CENTER AND TESTED THE AFFECTED DEVICE ON SITE. ALL TESTS WITH THE AFFECTED DEVICE WERE SUCCESSFUL AND IT WAS CONCLUDED BY THE OFFICIAL MEDELA REPRESENTATIVE THAT THE DEVICE IS WORKING AS EXPECTED. IT WAS CONFIRMED BY THE STAFF OF THE MEDICAL CENTER THAT THE CHECKS BEFORE USE AS DESCRIBED IN THE OFFICIAL INSTRUCTION FOR USE WERE NOT CONDUCTED. ADDITIONALLY, THE OFFICIAL MEDELA REPRESENTATIVE PROVIDED TRAINING TO THE MEDICAL STAFF OF THE MEDICAL CENTER ON THE PROPER USAGE OF THE VARIO PUMP. FURTHER, A TECHNICAL INVESTIGATION OF THE AFFECTED DEVICE WAS PERFORMED BY MEDELA AG. THE TECHNICAL INVESTIGATION SHOWED THAT THE AFFECTED DEVICE WAS INDEED WORKING ACCORDING TO SPECIFICATIONS. THE FINAL CONCLUSION OF MEDELA AG IS THAT THE AFFECTED DEVICE WAS PROPERLY WORKING AND DID NOT CAUSE THE INCIDENT.

    Additional Manufacturer Narrative · 0

    MEDELA AG IMMEDIATELY GOT IN CONTACT WITH THE RESPECTIVE MEDICAL CENTER IN ORDER TO COLLECT FURTHER RELEVANT INFORMATION TO THE CASE. IT WAS DECIDED TO SEND AN OFFICIAL MEDELA REPRESENTATIVE TO THE MEDICAL CENTER IN THE FOLLOWING DAYS IN ORDER TO VIEW AND CONFIRM THE SET UP AND HANDLING OF THE DEVICE. RETURN OF THE AFFECTED UNIT IS ALREADY UNDER WAY FOR A TECHNICAL INVESTIGATION.

    Description of Event or Problem · 0

    ON 3/15/2023, MEDELA AG WAS INFORMED THAT A PATIENT DIED IN A MEDICAL CENTER DURING A PROCEDURE INVOLVING AN AIRWAY SUCTION WITH THE AFFECTED DEVICE. ACCORDING TO THE MEDICAL CENTER IT IS STILL UNCLEAR IF THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT OR IF THE HANDLING OF THE DEVICE PLAYED A ROLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24307 VARIO18 AC/DC,100-240V,PT-C PUMP, PORTABLE, ASPIRATION (MANUAL OR POWERED) BTA MEDELA AG 026.5112 07612367016056

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death