BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 14737034 · Received June 17, 2022

    Report

    Report Number
    3000219639-2022-00029
    Event Type
    Malfunction
    Date Received
    June 17, 2022
    Date of Event
    April 26, 2022
    Report Date
    June 17, 2022
    Manufacturer
    SALTER LABS
    Product Code
    KZD
    UDI-DI
    10607411916912
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    117

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRESSURE BAG LEAKING PRESSURE COULD DELAY OR INTERRUPT THERAPY. THIS IS ATTACHED TO AN ARTERIAL LINE AND CAN IMPACT PATIENT THERAPY. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Additional Manufacturer Narrative · 0

    THE PRESSURE BAG LEAKING PRESSURE COULD DELAY OR INTERRUPT THERAPY. THIS IS ATTACHED TO AN ARTERIAL LINE AND CAN IMPACT PATIENT THERAPY. BASED ON THE REPORTED INFORMATION THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET. CAPA-00463 WAS INITIATED FOR THIS REPORTED FAILURE MODE. MANUFACTURE DATE OF THE PRODUCT ASSOCIATED WITH THIS COMPLAINT PRE-DATE IMPLEMENTATION OF CORRECTIVE ACTIONS OF CAPA-00463. RA: PRESSURE LEAKING CAUSED BY INADEQUATE OR DEFECTIVE MATERIALS INCLUDING GAUGES IS IDENTIFIED IN THE RISK ANALYSIS AT A 6 (MAJOR).

    Description of Event or Problem · 0

    THE PRESSURE DROPPED AFTER 1 HOUR OF USE.

    Description of Event or Problem · 0

    THE PRESSURE DROPPED AFTER 1 HOUR OF USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2044017 SALTER LABS INFUSOR,REUSABLE,INFUSEIT 500 ML W/STOPCOCK KZD SALTER LABS ZIT-520-5 2210906 10607411916912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other