BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2021898-2018-00104

    MDR report key: 7307526 · Received March 1, 2018

    Report

    Report Number
    2021898-2018-00104
    Event Type
    Injury
    Date Received
    March 1, 2018
    Date of Event
    June 16, 2017
    Report Date
    March 1, 2018
    PMA / PMN Number
    K833822
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS AND THERAPY DATES: BMN 190 (CERLIPONASE ALFA) SOLUTION FOR INFUSION (LOT# L241036); DOSE 300MG, QOW, INTRACISTERNAL; THERAPY DATE: (B)(6) 2017 TO UNKNOWN DATE. PLEASE SEE REPORT NUMBER: (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2016, THE PATIENT INITIATED TREATMENT WITH BMN 190 (300 MG, QOW, INTRACISTERNAL) WITH THE MOST RECENT DOSE OCCURRING ON (B)(6) 2017. ON (B)(6) 2017, THE OMMAYA 12 MM VENTRICULOSTOMY DEVICE WAS ASSESSED FOR INFUSION, AND CSF WAS OBTAINED AND CULTURED. THE PATIENT WAS ASYMPTOMATIC AND NO TREATMENT WAS ADMINISTERED. ON (B)(6)2017 (THREE DAYS OF CULTURE INCUBATION), THE CSF CULTURE WAS TESTED AND CONFIRMED THE GROWTH OF PROPIONIBACTERIUM ACNES. THE FOLLOWING DAY, THE DEVICE WAS AGAIN ASSESSED AND A CSF SAMPLE WAS DRAWN AND CULTURED. FIVE DAYS LATER ON (B)(6) 2017 THE CULTURE WAS AGAIN TESTED AND CONFIRMED THE GROWTH OF PROPIONIBACTERIUM ACNES. DUE TO CONSECUTIVE CULTURES WITH IDENTICAL BACTERIUM AND DISCUSSIONS WITH THE INFECTIOUS DISEASE PHYSICIANS, IT WAS DETERMINED THAT A TRUE POSITIVE CULTURE RATHER THAN A CONTAMINANT WAS OBTAINED. HOWEVER, DUE TO THE SUBJECT BEING ASYMPTOMATIC WITH NORMAL CSF LABS (PROTEIN, GLUCOSE, AND CELL COUNT), THE LOW BACTERIA COUNT WITHIN THE DEVICE, AND THE BACTERIA'S DELAYED GROWTH, IT WAS DETERMINED THAT REMOVING THE DEVICE AND ADMINISTERING ANTIBIOTICS WOULD BE MORE HARMFUL THAN LEAVING THE DEVICE WITHIN THE PATIENT. IT WAS CONFIRMED THAT THE EVENT WAS NOT MENINGITIS, BUT A DEVICE RELATED EVENT. ON (B)(6) 2017, THE PATIENT HAD ANOTHER ASSESSMENT AND INFUSION, WHICH CONFIRMED THE CSF CULTURE WAS NEGATIVE; HOWEVER THE EVENT WAS CONSIDERED ONGOING. THE HEALTH CARE PROVIDER (HCP) ASSESSED THE ETIOLOGY OF THE EVENT AS NOT RELATED TO THE BMN 190 TREATMENT, AND RELATED TO THE VENTRICULOSTOMY DEVICE. PLEASE SEE REPORT NUMBER: (B)(4).

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR Other