BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VITAL SIGNS® PRESSURE INFUSOR

    MDR report key: 11426662 · Received March 7, 2021

    Report

    Report Number
    3004050971-2021-00015
    Event Type
    Injury
    Date Received
    March 7, 2021
    Date of Event
    February 8, 2021
    Report Date
    February 8, 2021
    Product Code
    KZD
    UDI-DI
    10817357021063
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD REVIEW SHOW ALL UNITS WERE PROCEEDED LEAKAGE TEST ACCORDING TO WORK INSTRUCTION AND THE INSPECTION RECORD SHOWED THE SAMPLING INSPECTION OF MANUFACTURED LOT PASS ALL THE INSPECTION REQUIREMENT ON VISUAL AND PACKAGING REQUIREMENT. THE MWI-51004353-AS-004/A SHOWED THE ASSEMBLY METHOD WAS WELDING THE PVC TUBE WITH FLANGE WITH USING THE RF WELDING MACHINE . IN MWI-510043XX-AS-004 REV.:B. ,WHICH EFFECTIVE ON (B)(6) 2016, CYC WAS APPLIED FOR BONDING OF TUBE FLANGE AND 8 INCH PVC TUBE INSTEAD OF USING WELDING METHOD , DUE TO THE MATERIAL INCOMPATIBILITY CONTRIBUTES TO THE ROOT CAUSE OF THE NON WELD. DUE TO THE LACK OF MATERIAL FOR EVALUATION AND APPLICATION INFORMATION, THE ACTUAL FAILURE ANALYSIS COULD NOT BE PERFORMED. THE CAUSE OF REPORTED CASE IS CURRENTLY UNDETERMINED.

    Additional Manufacturer Narrative · 1

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT 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 VITAL SIGNS® PRESSURE INFUSOR HAS A LEAKING VALVE. IT HAPPENED DURING USE, AND THE MACHINE ALARMED "O2 CALIBRATION" AND "OCCLUSION." THE PATIENT HAD TO BE SEDATED FURTHER IN ORDER TO STOP THE ALARM FROM SOUNDING. HARM OR INJURY IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    324362 VITAL SIGNS® PRESSURE INFUSOR INFUSOR, PRESSURE, FOR I.V. BAGS KZD VITAL SIGNS® PRESSURE INFUSOR 10817357021063

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention