BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1802182 · Received August 17, 2010

    Report

    Report Number
    1423500-2010-02570
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENTS DISCARD THE SAMPLES AFTER EACH THERAPY, THEREFORE NO SAMPLE WAS RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF A PATIENT WHO DID NOT WEAR A MASK RESULTING IN PERITONITIS IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER'S CUSTOMER SERVICE, IT WAS REPORTED THAT THE PATIENT DID NOT WEAR A MASK. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. PER THE NURSE, THE CAUSE OF THE PERITONITIS WAS DUE TO THE PATIENT NOT WEARING A MASK. ON AN UNREPORTED DATE IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED BUT THE RESULTS WERE UNKNOWN AT THE TIME OF REPORTING. TREATMENT FOR THE PERITONITIS WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE; THEREFORE THE OUTCOME OF THE EVENT WAS CONSIDERED NOT REPORTED. DIANEAL THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AT THE TIME OF REPORTING. . PER THE NURSE, THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY. THE NURSE DID NOT PROVIDE A CAUSAL RELATIONSHIP BETWEEN THE EVENT OF "DID NOT WEAR A MASK" AND DIANEAL THERAPY. THIS IS THE MASTER COMPLAINT FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R 5B4826 1.5% LO/CAL 5L/5L DIANEAL, 5B4984 EXTRANEA