BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP

    MDR report key: 3130750 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13461
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 3, 2013
    Manufacturer
    BAXTER HEALTHCARE - CLEVELAND
    Product Code
    KDI
    PMA / PMN Number
    K895631
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT GD893883, AND NO ISSUES WERE DETECTED DURING THE MANUFACTURING OF THIS BATCH. (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 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT. IT WAS REPORTED THAT A PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THERAPIES WERE ONGOING. THE PATIENT EXPERIENCED A FEVER AND CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT BEGAN TREATMENT WITH VANCOMYCIN (IV, DOSE AND FREQUENCY NOT REPORTED) AND AN ADDITIONAL UNSPECIFIED ANTIBIOTIC FOR THE PERITONITIS. ON A LATER DATE, THE PATIENT RECOVERED FROM THE PERITONITIS AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231975 MINICAP DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - CLEVELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 29 MO Hospitalization| R MINICAP TRANSFER SET| HOMECHOICE, DIANEAL PD2 AMBUFLEX| HOMECHOICE LOW RECIRCULATION VOLUME APD SET