BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONO S-PID 50 PUMP

    MDR report key: 9763820 · Received February 26, 2020

    Report

    Report Number
    MW5093330
    Event Type
    Malfunction
    Date Received
    February 26, 2020
    Report Date
    February 14, 2020
    Manufacturer
    INTRA PUMP INFUSION SYSTEM
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SPONTANEOUS CALL, PT'S MOTHER STATED THEY ARE MISSING SUPPLIES AND THE PUMP IS BROKEN. LOT NUMBER AND EXP DATE ARE UNK. UNK IF PT EXPERIENCED AN ADVERSE EVENT DUE TO DEFECTIVE PRODUCT. PT HAS PRODUCT ON HAND TO RETURN. NO ADD'L INFO KNOWN OR PROVIDED. REPORTED TO (B)(6) BY PT/CAREGIVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220640 CRONO S-PID 50 PUMP INFUSION PUMP FRN INTRA PUMP INFUSION SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1