BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTED AUTOFEED HUMIDIFICATION CHAMBER

    MDR report key: 18567937 · Received January 23, 2024

    Report

    Report Number
    9611451-2024-00041
    Event Type
    Malfunction
    Date Received
    January 23, 2024
    Date of Event
    December 18, 2023
    Report Date
    December 25, 2023
    Manufacturer
    FISHER & PAYKEL HEALTHCARE LTD
    Product Code
    BTT
    PMA / PMN Number
    K934140
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE COMPLAINT (B)(6) VENTED AUTOFEED HUMIDIFICATION CHAMBER IS CURRENTLY EN ROUTE TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. WE WILL PROVIDE A FOLLOW UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). CORRECTIONS: SECTION D: D1, D2, D4 UPDATED TO REFLECT MR290V VENTER AUTOFEED HUMIDIFICATION CHAMBER AS THE SUBJECT DEVICE. SECIOTN G4: 510(K) NUMBER UPDATED TO K934140. SECTION H6: REMOVED MEDICAL DEVICE PROBLEM CODE 1250. SECTION H11: METHOD: THE SUBJECT MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER WAS RETURNED TO F&P HEALTHCARE IN NEW ZEALAND, WHERE IT WAS VISUALLY INSPECTED AND ANALYSED. RESULTS: VISUAL INSPECTION OF THE RETURNED MR290 VENTED AUTOFEED HUMIDIFICATION CHAMBER IDENTIFIED, WHITE RESIDUE ON THE OUTSIDE OF THE CHAMBER AND SEVERAL SMALL HOLES IN THE BASE OF THE CHAMBER. FURTHER ANALYSIS CONFIRMED THE PRESENCE OF SODIUM AND CHLORINE. CONCLUSION: THE RESULTS INDICATE THAT THE MOST LIKELY CAUSE OF HOLE FORMATION AND CORROSION OF THE ALUMINIUM CHAMBER BASE IS EXPOSURE TO SALINE SOLUTION (SODIUM CHLORIDE), WHICH REACTED WITH THE ALUMINIUM BASE. EVERY MR290V CHAMBER IS PRESSURE TESTED FOLLOWING THE MANUFACTURING PROCESS TO CHECK FOR ANY LEAKS PRESENT IN THE CHAMBER DUE TO CRACKS AND OTHER CAUSES. ANY CHAMBER WHICH FAILS THIS TEST IS REJECTED. IN ADDITION, THE PRESSURE TEST IS FOLLOWED BY A VISUAL INSPECTION OF EACH CHAMBER. NO CRACKS IN THE CHAMBER DOME ARE ACCEPTABLE. ANY CHAMBER THAT FAILS THIS INSPECTION IS REJECTED. OUR USER INSTRUCTIONS THAT ACCOMPANY THE MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER STATE THE FOLLOWING: - "USE USP STERILE WATER FOR INHALATION OR EQUIVALENT FOR HUMIDIFICATION. DO NOT ADD OTHER SUBSTANCES TO THE WATER." - "THE USE OF BREATHING CIRCUITS, CHAMBERS, ACCESSORIES OR COMBINATIONS WHICH ARE NOT APPROVED BY FISHER & PAYKEL HEALTHCARE MAY RESULT IN POOR HUMIDIFICATION SYSTEM PERFORMANCE, VENTILATOR MALFUNCTION AND HARM TO THE PATIENT/USER." - "DO NOT SOAK, WASH, STERILIZE, OR REUSE THIS PRODUCT. AVOID CONTACT WITH CHEMICALS, CLEANING AGENTS, OR HAND SANITIZERS." - "PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT." - "ENSURE APPROPRIATE VENTILATOR AND FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT."

    Description of Event or Problem · 0

    A DISTRIBUTOR IN JAPAN REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED WITH A RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT, WAS FOUND WITH MULTIPLE SMALL HOLES ON THE BASE OF THE CHAMBER. THE CUSTOMER HAS INDICATED THAT A SALINE SOLUTION WAS INTRODUCED TO THE CHAMBER FIVE DAYS BEFORE THE HOLES WERE OBSERVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    A DISTRIBUTOR IN (B)(6) REPORTED ON BEHALF OF A HEALTHCARE FACILITY, VIA A FISHER AND PAYKEL (F&P) HEALTHCARE FIELD REPRESENTATIVE, THAT DURING PATIENT USE A MR290V VENTED AUTOFEED HUMIDIFICATION CHAMBER, PROVIDED WITH A RT266 INFANT DUAL-HEATED EVAQUA2 BREATHING CIRCUIT, WAS FOUND WITH MULTIPLE SMALL HOLES ON THE BASE OF THE CHAMBER. THE HEALTHCARE FACILITY INDICATED THAT NEBULISED MEDICATIONS (SALINE AND BROMEHEXINE HYDROCHLORIDE) HAD BEEN ADMINISTERED VIA THE SYSTEM ON MULTIPLE OCCASIONS PRIOR TO THE HOLES BEING OBSERVED. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445971 VENTED AUTOFEED HUMIDIFICATION CHAMBER HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V UNKNOWN
    1899068 VENTED AUTOFEED HUMIDIFICATION CHAMBER HUMIDIFICATION CHAMBER BTT FISHER & PAYKEL HEALTHCARE LTD MR290V UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown CIRCUIT KIT: RT266 ADULT BREATHING CIRCUIT| HUMIDIFIER: MR850| NEBULISER: AEROGEN SOLO| VENTILATOR: SERVO-U