BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VITAL SIGNS PRESSURE INFUSOR

    MDR report key: 11771853 · Received May 4, 2021

    Report

    Report Number
    3004050971-2021-00019
    Event Type
    Malfunction
    Date Received
    May 4, 2021
    Date of Event
    February 14, 2021
    Report Date
    April 6, 2021
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    KZD
    UDI-DI
    10817357021063
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: NO SAMPLE WAS RETURNED FOR EVALUATION. THE STRUCTURE REVIEW WAS MADE FOR THE COMPLAINT PVC TUBING AND STOPCOCK. AND ACCORDING TO THE WORK INSTRUCTION MWI-51004353-AS-008/G, THE PVC TUBING AND STOPCOCK WERE ASSEMBLED WITHOUT GLUE, THE PVC TUBING MAYBE DEFORMED WHICH CAN CAUSE THE PVC TUBING AND STOPCOCK TO HAVE AIR LEAKAGE. THIS ISSUE WAS TRACED TO THE PRODUCT DESIGN, AND AS A CORRECTIVE AND PREVENTIVE ACTION, THE SCN 101216 WAS SUBMITTED TO VYAIRE FOR ADDING CYC FOR THE BONDING OF PVC TUBE AND STOPCOCK. THE INFUSOR PRODUCT LABEL FOR SPECIFIC SHELF TIME REQUIREMENTS WAS UPDATED AS WELL.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. NO ROOT CAUSE HAS BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE 500ML PRESSURE INFUSOR BAG MFG ITEM # IN800048 LOST PRESSURE MORE QUICKLY THAN NORMAL. THIS ISSUE OCCURRED WHILE CONNECTED TO A PATIENT AND THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667075 VITAL SIGNS PRESSURE INFUSOR INFUSOR, PRESSURE, FOR I.V. BAGS KZD VYAIRE MEDICAL VITAL SIGNS® PRESSURE INFUSOR 10817357021063

    Patients

    Seq Age Sex Outcome Treatment
    1