BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP CURLIN 6000CMS

    MDR report key: 19701925 · Received July 8, 2024

    Report

    Report Number
    MW5157124
    Event Type
    Malfunction
    Date Received
    July 8, 2024
    Date of Event
    July 3, 2024
    Report Date
    July 3, 2024
    Manufacturer
    MOOG / ZEVEX, INC.
    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

    (B)(6) RN SHE HAD REPROGRAMMED THE PUMP WITH THE NEW HYL'.(VIA DOSE AND IT WAS WORKING FINE. THEN IT REGISTERED AN ERROR AND SHE RESTARTED IT AND ADJUSTED PATIENT POSITION. STILL HAD AN ERROR SO SHE CHANGED THE TUBING AND REPRIMED IT. IT WORKED FOR A BIT BUT THEN SLOWED DOWN AND THERE IS ABOUT 20 ML LEFT. IT DOES NOT SEEM TO BE WORKING WELL, NO OTHER INFORMATION PROVIDED. NO ADVERSE EVENT(S) REPORTED DUE TO PRODUCT ISSUE. PUMP IS AVAILABLE FOR RETURN UPON PATIENT RETURN. SERIAL NUMBER IS (B)(6). MAINTENANCE DUE DATE: UNKNOWN. PUMP IS BEING REPLACED. REPORTED TO (B)(6) BY HEALTH PROFESSIONAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1271471 PUMP CURLIN 6000CMS PUMP, INFUSION FRN MOOG / ZEVEX, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 4 YR Male HYQVIA KIT| LIDOCAINE /PRILOCAINE CRM