BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMETRA II

    MDR report key: 6639598 · Received June 12, 2017

    Report

    Report Number
    MW5070394
    Event Type
    Injury
    Date Received
    June 12, 2017
    Date of Event
    May 27, 2017
    Report Date
    June 12, 2017
    Manufacturer
    FLOWONIX
    Product Code
    LKK
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    OVERDOSED TWICE IN 2 WEEKS BY FLOWONIX PROMETRA II PROGRAMMABLE PUMP AND CATHETER MODEL 13827, SERIAL/LOT # (B)(4), CAUSED BY EQUIPMENT MALFUNCTION, 1ST OVERDOSE (B)(6) 2017 WAS AT LEAST 3ML VS 250MCG DAILY DOSE. DOCTOR RESET AND REFILLED ON (B)(6) 2017. SECOND OVERDOSE (B)(6) 2017 WAS MEASURED AS A 2.3ML DOSE IN 8 HRS VS NORMAL 250MCG IN 24 HRS OF HYDROMORPHONE AND BACLOFEN. BOTH EQUIPMENT MALFUNCTIONS CAUSED STROKE LEVEL BLOOD PRESSURE (HIGH 220/198 - LOW 178/115) WHICH HAS NOT LOWERED A/O TIME I COMPLETED THIS FORM, SEVERE LETHARGY, 14 LBS WEIGHT LOSS, ER AND ECARE VISITS. THE FLOWONIX PUMP WAS SURGICALLY REMOVED/REPLACED (B)(6) 2017 WITH A MEDTRONIC DEVICE. DR (B)(6) IS IMPLANTING PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416654 PROMETRA II PROMETRA II LKK FLOWONIX 13827
    416655 PROMETRA II PROMETRA II LKK FLOWONIX 10HZ4A52X

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Life Threatening| R