FDA Adverse Event Injury Summary report: N

VAPOTHERM 2000 I

MDR report key: 676526 · Received December 6, 2005

Report

Report Number
MW1037376
Event Type
Injury
Date Received
December 6, 2005
Date of Event
August 18, 2005
Report Date
December 6, 2005
Manufacturer
VAPOTHERM, INC
Product Code
BTT
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
MO, US
Reporter Occupation
RISK MANAGER

Narratives

Description of Event or Problem · 1

NICU PT ON VAPOTHERM THERAPY, DEVELOPED RESPIRATORY DIFFICULTIES AND WAS REINTUBATED. TRACHEAL ASPIRATE CULTURE INITIALLY SHOWED "STAPH SPECIES". REC'D INFO RE: RALSTONIA AND VAPOTHERM THERAPY. SUBSEQUENT TRACHEA ASPIRATE CULTURES TESTED POSITIVE FOR RALSTONIA. INFECTION CONTROL CONTACTED THE CDC AS WELL AS AN OUTSIDE HOSP THAT HAD REPORTED A CONCERN FOR RALSTONIA INFECTIONS IN PTS WHO HAD BEEN TREATED WITH VAPOTHERM. AFTER CONSULTATION AND DISCUSSION WITH PICU, NICU, RESPIRATORY THERAPY AND INFECTION CONTROL, IT WAS DECIDED THAT HOSP WOULD STANDARDIZE ITS CLEANING PROCEDURES OF THE VAPOTHERM UNITS AND TAKE ADDITIONAL PRECAUTIONS ABOVE AND BEYOND THOSE RECOMMENDED BY THE CO TO ATTEMPT TO ENSURE THAT THEY DO NOT BECOME CONTAMINATED. THESE PRECAUTIONS INCLUDED TUBING CHANGES, CARTRIDGE CHANGES AND SURVEILLANCE CULTURES OF MACHINES WERE PERFORMED TO ASCERTAIN THAT THEY WERE CLEAN. DESPITE THESE INTERVENTIONS, HOSP FOUND 5 VAPOTHERM MACHINES THAT HAD BEEN CLENAED AND PROCESSED PRIOR TO USE TO BE CONTAMINATED WITH RALSTONIA ON SURVEILLANCE CULTURING. THESE MACHINES HAD ONLY BEEN IN USE ON PTS FROM LESS THAN 24 HOURS TO AT MOST 7 DAYS. DISCUSSIONS WITH THE CO HAVE NOT YIELDED ADD'L CLEANING RECOMMENDATIONS ABOVE AND BEYOND THOSE HOSP HAS ALREADY ENACTED. VAPOTHERM USE HAS BEEN DISCONTINUED IN INSTITUTION, PENDING FURTHER DATA AND ANALYSIS FROM THE CDC AND FDA. HOSP WILL CONTINUE DISCUSSIONS WITH THE CDC REGARDING VAPOTHERM.

Devices

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

Patients

Seq Age Sex Outcome Treatment
1 20 DAY Hospitalization| L