BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN PAINSMART IOD

    MDR report key: 5104113 · Received September 25, 2015

    Report

    Report Number
    1722139-2015-00021
    Event Type
    Malfunction
    Date Received
    September 25, 2015
    Date of Event
    April 14, 2014
    Report Date
    April 17, 2014
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    IN THE ABSENCE OF ANY FURTHER CLARIFICATION, MOOG WILL ASSUME THAT THE TERM "FREE FLOW" MEANS THE UNRESTRICTED FLOW OF FLUIDS THROUGH TUBING. THE PUMP WAS EVALUATED AND FOUND TO HAVE A BENT PLATEN (EQUIVALENT FUNCTION AS A DOOR - THE PIECE THAT SWINGS SHUT AND HOLDS THE ADMINISTRATION SET TUBING IN PLACE). BENT PLATENS ARE MOST OFTEN CAUSED BY A MECHANICAL SHOCK TO THE DEVICE WHILE THE DOOR IS OPEN. THE PUMP HAD MOST LIKELY EXPERIENCED A RECENT DROP OR OTHER IMPACT AGAINST A HARD SURFACE. MOOG STATES IN ITS USER MANUAL THAT ANY PUMP THAT APPEARS TO BE DAMAGED SHOULD NOT BE USED. FURTHERMORE, SINCE SOME FREE FLOW-CAUSING IMPACT-RELATED DAMAGE MAY NOT BE VISIBLE, USERS ARE INSTRUCTED THAT, "IF AT ANY TIME THE PUMP IS DROPPED OR HIT, THE PUMP MUST BE CHECKED FOR VOLUMETRIC ACCURACY PRIOR TO REUSE. THE PUMP CAN ONLY BE BROUGHT BACK INTO SERVICE IF THE VOLUMETRIC ACCURACY TEST PASSES PER THE USER MANUAL. IF THE PUMP FAILS VOLUMETRIC ACCURACY IT MUST BE RETURNED TO MOOG MEDICAL DEVICES GROUP FOR EVALUATION." (PP 5-6). IN THIS CASE, IS UNCLEAR WHETHER OR NOT THE USER FOLLOWED THE ABOVE-DESCRIBED PROCESS. DEVICE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED EXPERIENCING "CONSTANT FREE FLOW WHEN DOOR LEVER IS CLOSED."MOOG RECEIVED NO FURTHER INFORMATION FROM THE REPORTER.(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636970 CURLIN PAINSMART IOD INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1300-E7L2

    Patients

    Seq Age Sex Outcome Treatment
    1