BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 3842314 · Received June 1, 2014

    Report

    Report Number
    1416980-2014-17583
    Event Type
    Injury
    Date Received
    June 1, 2014
    Date of Event
    April 29, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND A BATCH REVIEW FOR POTENTIALLY ASSOCIATED LOT NUMBER(S) H14A23020 AND H14B03111 COULD NOT VERIFY THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. THE PERITONITIS WAS MANIFESTED AS ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AS ONSET, THE PATIENT BEGAN SELF-TREATMENT WITH VANCOMYCIN (2GRAMS, EVERY 4 DAYS) INTRAPERITONEALLY (IP) AND GENTAMICIN IP (320MG, ONCE) UNTIL A PRESCRIPTION WAS OBTAINED. THE VANCOMYCIN IP TREATMENT CONTINUED FOR 11 DAYS. THE PATIENT WAS WITHDRAWN FROM THE GENTAMICIN IP (320MG) AFTER ONE DOSE. FIVE DAYS AFTER THE ONSET OF PERITONITIS, THE PATIENT RESUMED TREATMENT WITH GENTAMICIN IP AT A DIFFERENT DOSE (120MG, EVERY 2 DAYS) AND THIS TREATMENT CONTINUED FOR FIVE DAYS. THE NEXT DAY, THE PATIENT RECEIVED AN INDIVIDUAL TREATMENT OF LEVOQUIN (750 MG, ONCE, ORALLY) AND ENDED THE VANCOMYCIN TREATMENT. THE NEXT DAY, THE PATIENT BEGAN TREATMENT WITH LEVOQUIN (500MG, EVERY 2 DAYS, FOR A TOTAL OF 7 DOSES). AT THE TIME OF THE REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320729 EXTENSION SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention HOMECHOICE AUTOMATED PD SET WITH CASSETTE| DIANEAL PD4 AMBUFLEX 4.25%| HOMECHOICE| MINICAP TRANSFER SET| MINICAP| DIANEAL PD4 AMBUFLEX 2.5%