BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICO70

    MDR report key: 11542063 · Received March 22, 2021

    Report

    Report Number
    3002807968-2021-00008
    Event Type
    Malfunction
    Date Received
    March 22, 2021
    Date of Event
    March 3, 2021
    Report Date
    March 22, 2021
    Manufacturer
    RADIOMETER MEDICAL APS
    Product Code
    JKA
    PMA / PMN Number
    K962158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    RADIOMETER HAS BECOME AWARE OF AN ISSUE WITH PICO70 ARTERIAL BLOOD SAMPLER. THE ISSUE RELATES TO THE STERILE BARRIER SYSTEM FOR THE PRODUCT. DURING INTERNAL STRESS TESTING ON PICO70 ARTERIAL BLOOD SAMPLERS A BREACH IN THE STERILE BARRIER SYSTEM WAS OBSERVED IN ONE SAMPLE .THE PROBLEM HAS ONLY BEEN OBSERVED INTERNALLY DURING TESTING. RADIOMETER HAS ON 2021-03-18 INITIATED A RECALL WITH RADIOMETER REF. FAN 915-415 OF ALL PICO70 BLOOD SAMPLERS. A CORRECTION AND REMOVAL REPORT WILL BE SUBMITTED TO THE FDA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435532 PICO70 PICO70 JKA RADIOMETER MEDICAL APS 956-519, 956-522 & 956-533

    Patients

    Seq Age Sex Outcome Treatment
    1