BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2844132 · Received November 25, 2012

    Report

    Report Number
    3004209178-2012-10723
    Event Type
    Malfunction
    Date Received
    November 25, 2012
    Report Date
    October 26, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: CATHETER: PRODUCT ID 8590-1, LOT# N275592, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED AND CONFIRMED VIA TELEMETRY THAT A CRITICAL ALARM OCCURRED DUE TO "ZERO ML RESERVOIR VOLUME" BEING REACHED. A LOW RESERVOIR ALARM DATE ALSO OCCURRED AND WAS NOTED ON (B)(6) 2012. THE EMPTY RESERVOIR ALARM DATE OCCURRED ON (B)(6) 2012. IT WAS INDICATED THAT THE PATIENT WAS ASYMPTOMATIC AND IN THE LAST TWO WEEKS WAS VISITED BY HOME HEALTH CARE. IT WAS ALSO NOTED THAT THE PATIENT HAD MISSED REFILLS IN THE PAST AS A RESULT OF AN "UNRELIABLE/NON-COMPLIANT" CAREGIVER/FAMILY. IT WAS NOTED THAT THERE W ERE SOME FINANCIAL ISSUES. IT WAS STATED THAT THEY DID "NOT HAVE FAITH IN THE DRUG INFUSION SYSTEM" AND WANTED THE PUMP EXPLANTED. THE OUTCOME OF THE PATIENT WAS NOT PROVIDED. THE DRUGS DELIVERED VIA PUMP WERE SALINE AND GABALON. ADDITIONAL INFORMATION HAD BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1