BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2091542 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06062
    Event Type
    Injury
    Date Received
    May 17, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 27, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SPECIFIC PRODUCT CODE FOR THE MINICAP TRANSFER SET IS UNKNOWN. THE BRAND NAME AND 510K HAVE BEEN PROVIDED IN THIS MDR. 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 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10G30067 AND H10H30032 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 (B)(6) AND IS A SPONTANEOUS REPORT BY A CONSUMER IN (B)(6) OF PERITONITIS AND NOT FEELING WELL IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE CONSUMER REPORTED THE FOLLOWING. ON AN UNREPORTED DATE IN 2011, THE PERITONEAL EFFLUENT INSIDE THE DRAIN BAG WAS DIRTY AND CLOUDY AND THE PATIENT WAS TAKEN TO THE EMERGENCY ROOM. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS NOT REPORTED. THE PATIENT WAS TREATED WITH VANCOMYCIN (DOSE AND FREQUENCY NOT REPORTED). IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND WAS RECOVERING. IN (B)(6) 2011, THE PATIENT WAS NOT FEELING WELL AND THE PATIENT WAS READMITTED TO THE HOSPITAL. TREATMENT WAS NOT REPORTED. IN (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE OUTCOME FOR THE EVENT NOT FEELING WELL WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. AN OPINION OF CASUALITY FOR PERITONITIS AND NOT FEELING WELL WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE