BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 3023134 · Received March 27, 2013

    Report

    Report Number
    1416980-2013-07398
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 6, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS NOT AVAILABLE FOR FURTHER ANALYSIS. A REVIEW OF MANUFACTURING RECORDS FOR POTENTIALLY ASSOCIATED LOTS H12J15038 AND H12H31095 REVEALED NO ISSUES OR DEVIATIONS FROM STANDARD PROCEDURE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT WAS HOSPITALIZED FOR 3 DAYS FOR PERITONITIS MANIFESTED BY LOW BLOOD PRESSURE AND FALL COINCIDENT WITH AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY USING BAXTER DISPOSABLE PRODUCTS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH VANCOMYCIN, INTRAPERITONEALLY (IP), FOR THE PERITONITIS EVENT (DOSAGE AND FREQUENCY WERE UNKNOWN). APD THERAPY WAS ONGOING DURING THE HOSPITALIZATION AND PERITONITIS EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS FEELING BETTER AND RECOVERING FROM THIS EVENT OF PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THIS TIME. THIS IS REPORT 3 OF 3 FOR THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126065 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R DIANEAL PD2 AMBUFLEX 1.5% AND 2.5%| HOMECHOICE