BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAPOTHERM 2000I

    MDR report key: 1025149 · Received April 4, 2008

    Report

    Report Number
    1125759-2008-00002
    Event Type
    Injury
    Date Received
    April 4, 2008
    Date of Event
    December 30, 2008
    Report Date
    March 11, 2008
    Manufacturer
    VAPOTHERM, INC.
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VAPOTHERM CONTACT HUH DR, ASSOCIATE DIR OF HOSP EPIDEMIOLOGY, PEDIATRICS AND CHILD HEALTH AND DIR OF RESPIRATORY CARE ON 03/17/08. DR STATED THAT SHE DID NOT HAVE ANY KNOWLEDGE OF A RALSTONIA ISSUE. DIR OF RESPIRATORY CARE STATED THAT THE PT WAS ON A 2000I WHILE AT HUH. SHE WAS NOT AWARE OF A RALSTONIA ISSUE BEFORE SHE WAS CONTACTED BY REPORTER. HUH DID NOT HAVE ANY KNOWN ISSUES WITH THEIR 2000I UNITS. SHE SAID THAT THEY ARE CONDUCTING THEIR OWN INVESTIGATION. ALTHOUGH IT IS UNCLEAR WHETHER THE SOURCE OF THE RALSTONIA INFECTION IS RELATED TO THE 2000I UNIT, VAPOTHERM IS FILING THIS MDR IN AN ABUNDANCE OF CAUTION IN ORDER TO FULLY COMPLY WITH THE REQUIREMENTS OF 21 CFR PART 803. VAPOTHERM/S EXPERIENCE WITH RALSTONIA MANNITOLILYTIA IN THE 2006 PRODUCT RECALL HAS DEVELOPED OUR RESPONSIBILITY TO WIDEN OUR INVESTIGATION TO INCLUDE THE UNITS AT HUH. VAPOTHERM WILL CONTINUE TO INVESTIGATE THE POSSIBILITY OF A RALSTONIA ISSUE WITH THE 2000I UNITS AT HUH AND REPORT ANY ADDITIONAL INFO IN A FOLLOW-UP TO THIS MDR REPORT.

    Description of Event or Problem · 1

    VAPOTHERM HAS BECOME AWARE OF AN EVENT WHICH BEGAN WITH A PT BEING TRANSFERRED FROM HOWARD UNIVERSITY HOSP (HUH) TO CHILDREN'S NATIONAL MED CTR (CNMC). THE PT HAD BEEN RECEIVING TREATMENT ON A 2000I UNIT AT HUH PRIOR TO TRANSFER TO CNMC. UPON ADMISSION TO CNMC, A BLOOD SAMPLE WAS TAKEN FROM THE PT AND IT TESTED POSITIVE FOR RALSTONIA PICKETTI. THE PT WAS THEN PLACED ON A 2000I MACHINE AT CNMC. VAPOTHERM BECAME AWARE OF THIS EVENT DURING ITS INVESTIGATION OF MDR #1125759-2008-00001 IN WHICH CNMC NOTIFIED VAPOTHERM THAT A CULTURE TAKEN FROM ONE OF ITS USED 2000I UNITS HAD TESTED POSITIVE FOR RALSTONIA PICKETTII. AS OF 2008, CNMC REPORTED THAT THE PT IS "DOING WELL."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization