BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN

    MDR report key: 1121959 · Received August 13, 2008

    Report

    Report Number
    2031921-2008-00026
    Event Type
    Malfunction
    Date Received
    August 13, 2008
    Date of Event
    June 9, 2008
    Report Date
    August 11, 2008
    Manufacturer
    CURLIN MEDICAL, INC.
    Product Code
    MEA
    Removal / Correction Number
    2031921-2008-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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 AND/OR FREE FLOW. 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 HAS A FREE FLOW PROBLEM. NO PT INJURY INVOLVED. NO VISUAL PHYSICAL DAMAGE ON THE PUMP. THE ANESTHESIOLOGIST REPORTED THAT IT SEEMED TO BE UNDER-INFUSING. UPON INVESTIGATION, THE BIOMED DISCOVERED THAT THE PUMP WAS OVER-INFUSING AND FREE FLOWED WHILE IN OFF POSITION. TESTING WAS DONE WITH THE PUMP OUT OF THE LOCKBOX WITH THE BAG HANGING ON THE POLE. FREE FLOW DID DECREASE WHEN TESTED IN THE LOCKBOX I.E. THE BAG AND PUMP AT THE SAME LEVEL. THERE ARE NO CONSIDERABLE VISUAL DAMAGE TO THE PUMP. THERE ARE A FEW "NICKS" ON TOP OF THE PUMP AND THE DOOR IS ABOUT 1/16" OF AN INCH FROM BEING FLUSH WITH THE PUMP.

    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