BEUDAMED
    FDA Adverse Event Summary report: N

    CURLIN PAINSMART IOD

    MDR report key: 5494575 · Received March 11, 2016

    Report

    Report Number
    1722139-2016-00261
    Date Received
    March 11, 2016
    Date of Event
    March 12, 2015
    Report Date
    April 28, 2015
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) IS FILING THIS MDR RETROSPECTIVELY BECAUSE THE CUSTOMER USER FACILITY SUBMITTED A MANDATORY MEDWATCH REPORT (MEDWATCH (B)(4)) STATING THAT THE CURLIN PAINSMART IOD PUMP EXPERIENCED AN ALARM AND DISPLAYS THE MESSAGE "ALARM REPLACE SET 3". THIS ALARM IS PART OF THE PAINSMART IOD SOFTWARE SAFETY SYSTEM TO PREVENT POTENTIAL HARM TO THE PATIENT. WHEN THE PUMP DETECTS THAT THE ADMINISTRATION SET MUST BE REPLACED THE ALARM IS ACTIVATED AND THE PUMP STOPS ANY PROGRAMMED THERAPY UNTIL A NEW ADMINISTRATION SET IS INSERTED. THEREFORE, IT IS (B)(4)'S POSITION THAT THE CURLIN PAINSMART IOD INFUSION PUMP THAT IS THE SUBJECT OF THIS COMPLAINT OPERATED WITHIN SPECIFICATIONS AS DETAILED IN THE PAINSMART IOD USER MANUAL AND NO MALFUNCTION OCCURRED. THE USER MANUAL STATES THE ALARM CONDITION AND RESOLUTION, AS FOLLOWS: "LCD DISPLAY: ***ALARM*** REPLACE SET 3. ALARM: REPLACE SET. CAUSE: THE PUMP HAS DETECTED THAT THE DISPOSABLE ADMINISTRATION SET MUST BE REPLACED: RESOLUTION: REPLACE THE DISPOSABLE ADMINISTRATION SET, PRIME THE SET IF NECESSARY, AND WHEN READY TO BEING INFUSING, SELECT RESUME TO CONTINUE THE INFUSION."

    Description of Event or Problem · 1

    CUSTOMER STATED: "PATIENT COMPLAINED PCA WAS BEEPING A LOT ERROR MESSAGE ALARM SET 3 APPEARTED AT APPROX 0845. REPLACED C BATTERIES , TURNED THE PUMP BACK ON, AND IT APPEARED TO BE WORKING. A REPLACEMENT PUMP WAS ORDERED. AT 1100 THE SAME MESSAGE APPEARED. OBTAINED NEW SYRINGE TUBING AND PUMP AND RESTARTED INFUSION." (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151400 CURLIN PAINSMART IOD INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1300P-E5L2 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR