BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CURLIN PCA

    MDR report key: 3809729 · Received May 8, 2014

    Report

    Report Number
    3809729
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    May 7, 2014
    Report Date
    May 8, 2014
    Manufacturer
    MOOG MEDICAL DEVICES
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    PCA MACHINE STARTED TO MALFUNCTION WHILE PATIENT WAS ADJUSTING FOR PAIN CONTROL. MACHINE INDICATED THAT BOLUS BUTTON WAS STUCK. MEDICATION STOPPED INFUSING. REPLACED PCA MACHINE.THIS FACILITY HAS HAD THE SAME EVENT TYPE OCCUR TWICE WITHIN A 2 DAY PERIOD THAT INVOLVED TWO DIFFERENT PCA MACHINES. NEITHER PATIENT WAS HARMED. THERE WAS A DELAY DELIVERING PAIN MEDICATION IN BOTH CASES UNTIL THE PCA MACHINES COULD BE CHANGED OUT.A REPRESENTATIVE OF CURLIN'S QUALITY CONTROL DIVISION FOLLOWED UP ON THIS REPORT AND PROVIDED INFORMATION FOR US TO SHARE WITH OUR FACILITY'S NURSING UNIT DIRECTORS AND STAFF. I HAVE CUT AND PASTED HER EDUCATIONAL MATERIAL BELOW, WHICH WAS PROVIDED AT OUR REQUEST. "IT WAS A PLEASURE SPEAKING WITH YOU TODAY. I HOPE THE FOLLOWING INFORMATION WILL BE OF SOME HELP TO YOUR STAFF, PREVENT THE UNNECESSARY RETURN OF PUMPS FOR SERVICING, FACILITATE UNINTERRUPTED THERAPY AND PROMOTE CONTINUED PATIENT COMFORT.RE: EC 179 STUCK BOLUS CORD SWITCHAN ERROR CODE 179 ON THE PAINSMART IOD IS ONE THAT MAY POSSIBLY BE CORRECTED. IT INDICATES A STUCK BOLUS BUTTON ON THE BOLUS CORD. IF THIS ERROR CODE OCCURS, TURN OFF THE PUMP AND REMOVE THE BOLUS CORD. (PLEASE REMOVE THE CORD BY THE GREEN SLEEVE LOCATED BY THE PORT. REMOVING THE CORD BY TUGGING THE CORD ITSELF CAN RESULT IN THE WIRES WITHIN THE BOLUS CORD BREAKING AND THEREFORE THE PATIENT MAY NOT BE ABLE TO OBTAIN BOLUS DOSES AS THE MESSAGE MAY NOT REACH THE PUMP.) THEN, TURN THE PUMP BACK ON AND REPLACE THE BOLUS CORD. RESUME THE INFUSION. PLEASE ADVISE THE PATIENT NOT TO HOLD DOWN THE BUTTON AS THE DELIVERY OF THE DOSE IS PROVIDED AFTER THE RELEASE OF THE BUTTON AND NOT UPON THE PRESS. INSTRUCTIONS PROVIDED TO THE PATIENT SHOULD PREVENT THIS OCCURRENCE.RE: SYRINGE USESHOULD A SYRINGE BE THE CONTAINER OF CHOICE, MOOG MEDICAL DEVICES GROUP RECOMMENDS TWISTING THE PLUNGER AT LEAST THREE TIMES PRIOR TO UTILIZING THE SYRINGE AND PERIODICALLY. SYRINGE FUNCTION CAN BE ADVERSELY AFFECTED BY VARIATIONS IN PLUNGER DIMENSION AND LUBRICITY, WHICH CAN RESULT IN GREATER FORCE REQUIRED TO MOVE THE SYRINGE PLUNGER. A SYRINGE PLUNGER WILL LOSE LUBRICATION AS IT AGES AND, RESULTING IN THE AMOUNT OF UNDER-DELIVERY INCREASING WHICH COULD ON OCCASION, BE SIGNIFICANT. THEREFORE, THE TYPE OF MEDICATION AND DELIVERY ACCURACY REQUIRED MUST BE CONSIDERED WHEN USING A SYRINGE WITH THE CURLIN® INFUSION PUMP.IN ORDER TO DETERMINE WHETHER UNDER-DELIVERY IS OCCURRING, CLINICIANS MUST REGULARLY COMPARE THE VOLUME REMAINING IN THE SYRINGE WITH THE REMAINING VOLUME LISTED ON THE SCREEN OF THE PUMP. TAKE CAUTION WHEN ADJUSTMENT IN DOSAGE IS ORDERED SINCE DELIVERY OF MEDICATION MAY FLUCTUATE WITH SYRINGE USE. AND DON'T FORGET TO TWIST, NOT PUSH, THE PLUNGER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279652 CURLIN PCA PUMP, INFUSION, PCA MEA MOOG MEDICAL DEVICES 4000 *
    279653 CURLIN PCA PUMP, INFUSION, PCA MEA MOOG MEDICAL DEVICES 4000 *

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR
    2 20 YR