BEUDAMED
    FDA Adverse Event Summary report: N

    MEDICATION CASSETTE RESERVOIR WITH NON-VENTED STOPPER

    MDR report key: 761731 · Received October 5, 2005

    Report

    Report Number
    MW4004222
    Date Received
    October 5, 2005
    Manufacturer
    *
    Product Code
    FPA
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    OUR FACILITY USES DELTEC, INC. TUBING AND CASSETTES FOR THE ADMINISTRATION OF EPOPROSTENOAL. CONCERN HAS BEEN RAISED (AND CASES OF HARM REPORTED) REGARDING THE ERROR PRONE DESIGN OF THE TUBING. THE TUBING ONLY ALLOWS ONE-WAY FLOW. THE COLOR CODED ENDS ARE EXTREMELY SIMILAR IN COLOR (LIGHT PURPLE AND LIGHT BLUE) AND DO NOT REALLY HELP TO PREVENT AN ERROR. SO, WHEN THE INCORRECT END OF THE TUBING ISCONNECTED TO THE CASSETTE, THE RESULT CAN BE THAT AN OMISSION OF DELIVERY OF THE MEDICATION MAY OCCUR. NATURALLY, DUE TO THE NATURE OF EPOPROSTENOL, OMISSION OF DELIVERY OF THE MEDICATION MAY RESULT IN A SERIOUS OUTCOME FOR THE PT. ERRORS HAVE OCCURRED AT OUR ORGANIZATION BECAUSE OF THIS ISSUE. THE MOST SEVERE HARM COULD BE CATEGORIZED AS A NCC MERP CATEGORY H. (THE PATIENT CODED; PHARMACIST RELAIZED THAT IT WAS BECAUSE THE TUBING HAD BEEN REVERSED AND THEREFORE THE PT HAD NOT REC'D THE EPOPROSTEONAL FOR AN UNDETERMINED PERIOD OF TIME.) BELIEVE IT OR NOT, THE PHARMACIST WAS NOT THE ONE TO BRING THE ISSUE TO MY ATTENTION. OUR FACILITY HAS IMPLEMENTED A PROCESS WHEREBY THE PHARMACY DEPT PLACES A STICKER ON THE END OF THE TUBING WITH THE FILTER THAT INDICATES "FILTER END TO PT," WHICH SERVES AS A REMINDER TO THE NURSING STAFF. WE HAVE ACKNOWLEDGED THAT THIS IS NOT AN OPTIMAL OR FULLY ERROR-PROOF SOLUTION. IN ORDER TO PREVENT THESE ERRORS FROM OCCURRING, IT WOULD BEHOOVE DELTEC, INC TO PREVENT THE INCORRECT END OF THE TUBING FROM ATTACHING TO THE CASSETTE. IN OTHER WORDS, WE HAVE ENCOURAGED THE CO TO INCORPORATE HUMAN FACTORS IN ENGINEERING AND FORCING FUNCTIONS IN THEIR DESIGN, NOW THAT WE HAVE BROUGHT THIS TO THEIR ATTENTION. WE HAVE YET TO RECEIVE A RESPONSE THAT HAS INDICATED THAT THEY HAVE ANY PLANS FOR A REDESIGN. ONE OF OUR IV ROOM PHARMACISTS BROUGHT THE ISSUE TO MY ATTENTION. HE NOTICED THE ISSUE BECAUSE THE PHARMACISTS ALWAYS ATTACH THE PRIMED TUBING TO THE CASSETTE PRIOR TO DISPENSING. THE PHARMACISTS ALWAYS LOOK FOR THE BLUE MALE END OF THE TUBING TO ATTACH TO THE BLUE FEMALE END OF THE TUBING FROM THE CASSETTE. RECENTLY, DELTEC MADE SOME COLOR CHANGES (APPARENTLY TO BE COMPLIANT WITH SOME OTHER REGULATORY ISSUES) AND THE COLOR CHANGES PROMPTED THE PHARMACIST TO NOTICE THE POTENTIAL FOR ERROR. IN OTHER WORDS, THE CO WILL TELL YOU BLUE STILL ATTACHES TO BLUE, BUT WHEN YOU PUT THE PURPLE TUBING END BESIDE THE BLUE END OF THE TUBING FROM THE CASSETTE IT IS HARD TO TELL IF THE FEMALE END FROM THE CASSETTE IS BLUE OR PURPLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICATION CASSETTE RESERVOIR WITH NON-VENTED STOPPER MEDICATION CASSETTE RESERVOIR WITH NON-VENTED STOPPER FPA * * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * FLOLAN| EPOPROSTENOL GLAXOSMITHKLINE