BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3950602 · Received July 22, 2014

    Report

    Report Number
    3004209178-2014-13367
    Event Type
    Injury
    Date Received
    July 22, 2014
    Date of Event
    June 26, 2014
    Report Date
    June 30, 2014
    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
    OR, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8780, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT'S PUMP WAS PLACED SO HIGH THAT IT FELT LIKE IT WAS IN HER RIBS. LAST THURSDAY, THEY OPENED UP THE POCKET MORE TO MOVE THE PUMP DOWN. IT WAS NOTED THE PATIENT'S RATE HAD BEEN INCREASED BY ANOTHER HEALTHCARE PROFESSIONAL (HCP) SO WHEN THEY WENT IN FOR SURGERY THE PUMP WAS ALARMING DUE TO A LOW RESERVOIR ALARM. IT WAS NOTED THE OTHER HCP TURNED THE PATIENT UP MULTIPLE TIMES AND HAD NOT NOTIFIED THE MANAGING HCP OF THE RATE CHANGE SO THEY HAD BEEN EXPECTING THE REFILL TO BE IN (B)(6). IT WAS NOTED THE SURGERY FACILITY DID NOT HAVE THE REQUIRED DRUG TO FILL THE PUMP SO THE PATIENT WAS SENT TO THEIR HOMECARE FACILITY THE DAY AFTER THE REVISION TO REFILL THE PUMP. IT WAS NOTED THE AREA WAS VERY SWOLLEN AND IT WAS UNCOMFORTABLE FOR THE PATIENT TO HAVE TO BE "STUCK" THAT SHORTLY AFTER SURGERY. THE PATIENT WAS UPSET ABOUT THIS. THE PUMP WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    428034 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention