BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN 6000

    MDR report key: 16630141 · Received March 28, 2023

    Report

    Report Number
    MW5116034
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Report Date
    March 20, 2023
    Manufacturer
    MOOG COSTA RICA, SRL
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PER (B)(6), NURSE WITH INFUSIONS, NEW PUMP RECEIVED LAST MONTH HAS HAD MULTIPLE ISSUES INCLUDING 'EMPTY BATTERIES' AND 'AIR ALARM'. PUMP USED TO INFUSE LUMIZYME SDV AT ABOVE DOSE AND FREQUENCY. NEW PUMP WAS SENT NO ADVERSE EVENTS REPORTED. NO MISSED DOSES REPORTED. PRODUCT LOT NUMBER AND EXPIRATION DATE UNKNOWN. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766210 CURLIN 6000 PUMP, INFUSION FRN MOOG COSTA RICA, SRL

    Patients

    Seq Age Sex Outcome Treatment
    1 Male