BEUDAMED
    FDA Adverse Event Other Summary report: N

    VAPOTHERM 2000I

    MDR report key: 792900 · Received April 6, 2006

    Report

    Report Number
    1125759-2006-00010
    Event Type
    Other
    Date Received
    April 6, 2006
    Report Date
    March 4, 2006
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Removal / Correction Number
    Z-0360-06
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VAPOTHERM USERS REPORT THAT RALSTONIA HAD BEEN ISOLATED IN SOME VAPOTHERM DEVICES. IN A TELEPHONE INTERVIEW WITH RN OF REGIONAL SHE STATED THAT THE HOSP HAD CLEANED THE VAPOTHERM DEVICES AND CULTURED THEM. THE DEVICES WERE CULTURED LESS THAN ONE MONTH AFTER CLEANING. HOWEVER, RN STATED THAT 6 UNITS HAD NOT BEEN CLEANED PRIOR TO THE NOVEMBER CLEANING IN "QUITE SOME TIME." FOLLOWING THE NOVEMBER CLEANING 7 OF 10 UNITS HAD A POSITIVE CULTURE FOR RALSTONIA. SHE STATED THEY ALSO CULTURE RALSTONIA IN 5 USED VAPOR TRANSFER CARTRIDGES AND DID NOT FIND RALSTONIA IN NEW CARTRIDGES. VAPOTHERM RECEIVED THE REGIONAL VAPOTHERM DEVICES AS PART OF A RECALL TO ADDRESS RALSTONIA ON 1/24/06. VAPOTHERM RECEIVED AN EDITED REPORT FROM FDA IN THE MATTER ON 3/3/06. THIS MATTER IS ADDRESSED AS PART OF RECALL. IT IS IMPORTANT TO NOTE, THE HOSP REPORTED ONLY EQUIPMENT COLONIZATION AND CONFIRMED NO PT INFECTION AND NO PT INJURY.

    Description of Event or Problem · 1

    RECENTLY, VAPOTHERM, A HIGH FLOW NASAL CANNULA OXYGEN DELIVERY DEVICE, HAS BEEN REPORTED TO GROW RALSTONIA SPECIES. AFTER IMPLEMENTING THE NEW CLEANING RECOMMENDATIONS FROM VAPOTHERM - PUBLISHED 11/05. RALSTONIA SPP. WAS CULTURED FROM 7 TO 10 IN-USE VAPOTHERM UNITS. LENGTH OF TIME IN USE RANGED FROM 6 - 30 DAYS. ALL UNITS HAD BEEN CLEANED USING THE NEW RECOMMENDATIONS. ALL VAPOTHERM UNITS HAVE BEEN DISCONTINUED FROM USE. VAPOTHERM SPOKE WITH RN THREE TIMES IN RESPONSE TO THIS REPORT FROM MARCH 7 THROUGH APRIL 4. RN CONFIRMED THERE WERE NO REPORTS OF INFECTION OR INJURY ASSOCIATED WITH THE COLONIZATION OF RALSTONIA FROM VAPOTHERM EQUIPMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAPOTHERM 2000I HUMIDIFIER BTT VAPOTHERM, INC. 2000I *

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other