BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2920952 · Received January 17, 2013

    Report

    Report Number
    1416980-2013-01299
    Event Type
    Injury
    Date Received
    January 17, 2013
    Date of Event
    December 1, 2012
    Report Date
    December 26, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. NO ASSIGNABLE CAUSE WAS DETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBERS H12E29053 AND H12J15038 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 2 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION PROVIDED BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT'S WIFE THOUGHT IT MIGHT BE FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS. PER THE NURSE, THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26649 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE