BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3133209 · Received May 29, 2013

    Report

    Report Number
    1416980-2013-13572
    Event Type
    Injury
    Date Received
    May 29, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H12F21058, H12G23052, H12H29057, H12I06079, H12G19068, H12J26076, H12J03034, H12L11074 AND H13B22021. THERE WERE NO EXCEPTIONS NOTED DURING MANUFACTURE OF THESE LOTS RELATED TO THE REPORTED CONDITION. THIS IS THE SAME PATIENT AS (B)(4). SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPIES WERE ONGOING. AS A RESULT OF THE PERITONITIS, THE PATIENT EXPERIENCED DIARRHEA AND STOMACH ISSUES. THE PATIENT WAS NOT HOSPITALIZED FOR THE PERITONITIS AND THE CAUSE OF THE EVENT WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED PROPHYLACTIC ANTIBIOTICS FOR THE PERITONITIS. ON A LATER DATE, THE PATIENT RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234972 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HOMECHOICE, DIANEAL PD4 AMBUFLEX| FLEXICAP, MINICAP| HOMECHOICE AUTOMATED PD SET WITH CASSETTE