BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 1121962 · Received August 13, 2008

    Report

    Report Number
    2031921-2008-00022
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    May 28, 2008
    Report Date
    August 8, 2008
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    MEA
    Removal / Correction Number
    2031921-2008-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: DEVICE WAS CONFIRMED TO HAVE A BENT DOOR DUE TO BEING DROPPED. CONCLUSIONS: DEVICE WAS REPAIRED TO SPECIFICATION. THE DOOR ASSEMBLY WAS REPLACED, THE PUMP FULLY TESTED PER PROCEDURE AND RETURNED FOR CUSTOMER USE. 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 PUMP TESTING, NOT WHILE ON A PT. THERE WAS NO PT INVOLVED. IT WAS ALSO REPORTED THAT THE PUMP DOOR LOCK IS BENT, AND THE DOOR COULD NOT CLOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CURLIN INFUSION PUMP PAINSMART IOD MEA CURLIN MEDICAL, INC. 360-1301

    Patients

    Seq Age Sex Outcome Treatment
    1