BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3063403 · Received April 17, 2013

    Report

    Report Number
    3004209178-2013-06435
    Event Type
    Malfunction
    Date Received
    April 17, 2013
    Report Date
    March 20, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, LOT # N180042004, IMPLANTED: (B)(6) 2009, PRODUCT TYPE CATHETER; PRODUCT ID 8840, SERIAL # UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A LOW RESERVOIR ALARM DATE APPEARED THE SAME DATE THAT THE PUMP WAS PROGRAMMED. THE PATIENT'S PUMP WAS FILLED LAST WEEK AND WHEN THE HEALTH CARE PROVIDER WAS GETTING READY TO FORWARD THE PRINTOUT TO THE DOCTOR AND PHARMACIST, THEY NOTICED THE LOW RESERVOIR ALARM DATE AND WASN'T SURE IF IT WAS RIGHT. THE REPORTER STATED, "SO I DON'T KNOW IF THAT'S RIGHT OR IF SHE FORGOT TO HIT UPDATE OR SOMETHING ON THE PUMP." IT WAS NOTED THAT THE PATIENT HAD NOT REPORTED HEARING ANY ALARMS AND HAD NOT COMPLAINED OF ANY PROBLEMS WITH THERAPY. THE DEVICE SYSTEM WAS USED TO ADMINISTER HYDROMORPHONE. IT WAS LATER REPORTED THE RESERVOIR ALARM WAS NOT UPDATED AND THE PUMP UPDATE DIDN'T COMPLETE ON (B)(6) 2013 AFTER A PUMP REFILL. IT WAS NOTED THERE WAS NO SESSION DATA REPORT FROM (B)(6) 2013 IN THE PHYSICIAN PROGRAMMER REPORTS. THE HEALTH CARE PROVIDER PLANNED TO GO SEE THE PATIENT ON THE DAY OF THIS REPORT TO CORRECT THE ERROR. IT WAS LATER REPORTED THAT THE HEALTH CARE PROFESSIONAL THAT HAD FILLED THE PATIENT'S PUMP SOMEHOW MISSED THE UPDATE SPOT "OR STAGE AT THE END." IT WAS ALSO NOTED THAT THE PATIENT "ALWAYS HAS A LOT OF RESIDUAL LEFT OVER AND IF YOU WANT TO DATE IT FROM TODAY HE WOULD STILL BE FINE. FROM THE READING LAST WEEK, IT LOOKED LIKE THERE WAS A LITTLE OVER TWO ML OF MEDICATION LEFT. THERE WAS 7 ML TO START WITH; AFTER THE SPILL, SHE ENDED UP COLLECTING TWO." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THAT THE EVENT WAS DUE TO A USER ERROR AND THE PUMP JUST NEEDED TO BE UPDATED. THERE WERE NO PATIENT SYMPTOMS OR HARM AND NO ISSUES WITH THE PROGRAMMER. THE PUMP HAD BEEN UPDATED AND THE PATIENT WENT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164723 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00035 YR