BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 1121951 · Received August 13, 2008

    Report

    Report Number
    2031921-2008-00025
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    June 6, 2008
    Report Date
    August 11, 2008
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    FRN
    Removal / Correction Number
    2031921-2008-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE WAS CONFIRMED TO HAVE A BENT DOOR, WHICH RESULTS FROM BEING DROPPED. THE BENT DOOR WAS DISCOVERED DURING ROUTINE MAINTENANCE AND CAN DIRECTLY CAUSE OVERINFUSION. CONCLUSIONS: DEVICE WAS REPAIRED TO SPECIFICATION. THE DOOR ASSEMBLY WAS REPLACED, THE PUMP FULLY TESTED PER PROCEDURE. THE DOOR ASSEMBLY CAN BECOME BENT WHEN DROPPED OR DAMAGED FROM USE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP OVERINFUSED DURING TESTING AND THAT THERE WAS NO VISIBLE DAMAGE. REPORTED THAT THE USERS WERE NOT AWARE OF IT BEING DROPPED. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION PUMP 4000PLUS FRN CURLIN MEDICAL, INC. 350-1001

    Patients

    Seq Age Sex Outcome Treatment
    1