BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROTEK

    MDR report key: 19015050 · Received April 1, 2024

    Report

    Report Number
    3012811961-2024-00006
    Event Type
    Malfunction
    Date Received
    April 1, 2024
    Date of Event
    March 1, 2024
    Report Date
    April 1, 2024
    Manufacturer
    ECOLAB/MICROTEK INC
    Product Code
    PUI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    501

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THERE WAS A SMALL HOLE IN DRAPE NEAR PLATE, CAUSING CONTAMINATION TO SALINE. SALINE USED TO PRIME PERFUSION PUMP LINER PRIOR TO KNOWLEDGE OF HOLE, PERFUSION PUMP HAD TO BE BROKEN DOWN AND SET UP AGAIN, CONTAMINATED AREAS WERE REPLACED. NO PATIENT INJURIES, INFECTIONS OR COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1589517 MICROTEK SLUSH + WARMER PLATE-DRAPE¿ PUI ECOLAB/MICROTEK INC ORS-331 2123LA2000

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown