BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1852380 · Received October 4, 2010

    Report

    Report Number
    1423500-2010-04035
    Event Type
    Injury
    Date Received
    October 4, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT DISCARDED SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR THE SUSPECT LOT NUMBER (H10E03019), WITH NO DEFECTS NOTED.

    Description of Event or Problem · 1

    ON AN UNREPORTED DATE, THE PATIENT BEGAN PERITONEAL DIALYSIS TREATMENT. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6)2010, THE PATIENT DEVELOPED AND WAS HOSPITALIZED FOR PERITONITIS. PER THE NURSE, THE CAUSE OF THE PERITONITIS WAS "HARD TO TELL WITH THIS PATIENT, THE EVENT IS REOCCURRING". A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH REVEALED A GRAM NEGATIVE ORGANISM. IT WAS UNREPORTED WHETHER TREATMENT WAS PROVIDED. ON AN UNREPORTED DATE IN 2010, PD THERAPY WAS WITHDRAWN. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE PERITONITIS WAS UNRELATED TO PD THERAPY.

    Description of Event or Problem · 1

    PT SCHEDULED FOR LAPAROSCOPIC HERNIA REPAIR IN OPERATING ROOM (B)(6). DURING THE PROCEDURE, MD WAS USING A LAPAROSCOPIC TROCAR: (B)(4). HE SAID IT WOULD NOT "DEPLOY" PROPERLY. HE WAS GIVEN A REPLACEMENT WITH THE SAME RESULT. AFTER THE THIRD TROCAR, HE WAS ABLE TO USE THE TROCAR AND COMPLETE THE CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R DIANEAL PD4 AMBUFLEX, DIANEAL PD4 ULTRABAG