BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3040083 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04837
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Report Date
    March 11, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 8835, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 8781, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE EMERGENCY ROOM WITH INCREASED PAIN AND A SMALL AMOUNT OF BLOOD AT THE INSERT SITE. IT WAS NOTED THAT HER PAIN DRAMATICALLY INCREASED FROM 6AM. NO PUMP ALARM WAS HEARD, BUT THE NURSE FELT THAT THE PUMP WAS "NOT INFUSING RIGHT." THE ATTENDING PHYSICIAN WANTED TO TURN THE DEVICE OFF AND PUT THE PATIENT ON INTRAVENOUS MEDICATION, BUT COULDN'T DUE TO THE LACK OF A PROGRAMMING DEVICE. AT THE TIME OF REPORT, THE PLAN WAS TO CONTACT THEIR "QUORUM LADY" TO ASSIST WITH THE EVENT. THE DRUG USED IN THE SYSTEM WAS UNKNOWN.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THERE WAS NOTHING WRONG WITH THE DEVICE. THE DEVICE HAD ACTUALLY BEEN EXTRAORDINARILY HELPFUL TO THE PATIENT THE PAST SIX MONTHS. THE ONLY REASON THE PATIENT WAS ALLOWED TO GO HOME WAS BECAUSE THE PUMP WAS PLACED AND IT HAD MANAGED THE PATIENT'S PAIN VERY WELL. IT WAS NOTED THAT THE PATIENT WAS IN THE STAGE OF THE CANCER WHERE SHE WAS ACTIVELY DYING. THE PAIN THAT WAS BEING EXPERIENCED WAS NORMAL AND NOT DUE TO ANY ISSUE WITH THE PUMP. THE PATIENT WAS NEVER RE-ADMITTED TO THE HOSPITAL. THE PATIENT WAS IN HOSPICE BECAUSE SHE WAS DYING AND THE PUMP WAS STILL IMPLANTED AND WORKING TO MANAGE HER PAIN. THE PHYSICIAN WAS WORKING CLOSELY WITH HOSPICE WITH REGARD TO DOSING IV MEDICATIONS. THE PHYSICIAN HAS NOT ORDERED THE PUMP TO BE TURNED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142599 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1