BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SALTER LABS

    MDR report key: 14658263 · Received June 10, 2022

    Report

    Report Number
    3000219639-2022-00026
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    April 22, 2022
    Report Date
    June 10, 2022
    Manufacturer
    SALTER LABS
    Product Code
    KZD
    UDI-DI
    10607411916912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTABLE AS DISCONNECTION HAPPENED DURING USE DELAYING PATIENT THERAPY. CAPA-00463 WAS INITIATED FOR SIMILAR COMPLAINT. MANUFACTURING DATE FOR LOT 20210927 PRE-DATES THE IMPLEMENTATION ACTIVITIES OF CAPA-00463. CUSTOMER WAS NOTIFIED THAT THIS COMPLAINT, ALONG WITH SEVERAL OTHERS SUBMITTED BY THE SAME CUSTOMER, ARE TIED TO CAPA-00463 AND AN UPDATE WOULD BE PROVIDED ONCE CAPA ACTIONS ARE IMPLEMENTED. CUSTOMER HAS NOT REQUESTED ADDITIONAL FOLLOW UP AT THIS TIME (REFERENCE (B)(4).

    Additional Manufacturer Narrative · 0

    REPORTABLE AS DISCONNECTION HAPPENED DURING USE DELAYING PATIENT THERAPY. (B)(4) WAS INITIATED FOR SIMILAR COMPLAINT. MANUFACTURING DATE FOR LOT 20210927 PRE-DATES THE IMPLEMENTATION ACTIVITIES OF (B)(4). CUSTOMER WAS NOTIFIED THAT THIS COMPLAINT, ALONG WITH SEVERAL OTHERS SUBMITTED BY THE SAME CUSTOMER, ARE TIED TO CAPA-00463 AND AN UPDATE WOULD BE PROVIDED ONCE CAPA ACTIONS ARE IMPLEMENTED. CUSTOMER HAS NOT REQUESTED ADDITIONAL FOLLOW UP AT THIS TIME (REFERENCE COMPLAINT-07296) SUMMARY: CAPA-00463 CREATED FOR THIS REPORTED FAILURE MODE. MANUFACTURING LOT PRE-DATES CAPA CORRECTIVE ACTION IMPLEMENTATION. 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 GAUGE DISCONNECTED FROM THE TUBING.

    Description of Event or Problem · 0

    THE GAUGE DISCONNECTED FROM THE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    749842 SALTER LABS INFUSOR,REUSABLE,INFUSEIT 500 ML W/STOPCOCK KZD SALTER LABS ZIT-520-5 20210927 10607411916912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other