BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3063273 · Received April 17, 2013

    Report

    Report Number
    1416980-2013-09524
    Event Type
    Injury
    Date Received
    April 17, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS NO SAMPLE WAS RETURNED, AN EVALUATION COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR THE POTENTIALLY ASSOCIATED LOT NUMBER GD893578. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3. THIS IS A REPORT OF PERITONITIS AND BLOODY EFFLUENT IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ON AN UNKNOWN DATE, THE PATIENT STOPPED PD THERAPY AND BEGAN HEMO DIALYSIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. IT WAS REPORTED THAT MESH WAS FOUND IN AND AROUND WHERE THE CATHETER WAS. THE CAUSE OF BLOODY EFFLUENT WAS RELATED TO THE PD CATHETER BEING POSITIONED TOO HIGH IN THE ABDOMINAL CAVITY BUT FURTHER INFORMATION WAS UNAVAILABLE REGARDING THIS ISSUE. THE CAUSE OF PERITONITIS WAS UNKNOWN. TREATMENT WAS UNKNOWN. THE PATIENT WAS RECOVERING FROM THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164227 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization DIANEAL 4.25% PD4| HOMECHOICE| DIANEAL 1.5% PD4| DIANEAL 2.5% PD4