BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2032235 · Received March 29, 2011

    Report

    Report Number
    1423500-2011-03775
    Event Type
    Injury
    Date Received
    March 29, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    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 AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, 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). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10J26110, H10I29065 AND H10I16070 WITH NO DEFECTS NOTED. 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 FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT REPORTED THE FOLLOWING. ON AN UNREPORTED DATE, THE PATIENT HAD THE CATHETER CHANGED. IN (B)(6) 2011, THE PATIENT DEVELOPED PERITONITIS AND WAS NOT HOSPITALIZED. TREATMENT WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. ON AN UNREPORTED DATE IN 2011, THE PATIENT HAD RECOVERED. THE CONSUMER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other DIANEAL PD4 AMBUFLEX| HOMECHOICE PD CYCLER