BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPACT EXCHANGE DEVICE

    MDR report key: 2122829 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07572
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDJ
    PMA / PMN Number
    K851208
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DAY. THE CAUSE OF THE PERITONITIS MAY HAD BEEN A PRIOR INFECTION TO THE INTESTINE. TREATMENT WAS NOT REPORTED. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL IN THE HOSPITAL AND WAS RECOVERING. DIANEAL THERAPIES WERE ONGOING. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPACT EXCHANGE DEVICE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX| HOMECHOICE