BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3130557 · Received May 24, 2013

    Report

    Report Number
    1416980-2013-13414
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    May 2, 2013
    Report Date
    May 2, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) EXPERIENCED A LEAK DUE TO DISCONNECTION OF THE TRANSFER SET AND THE TITANIUM ADAPTER, AND A BREACH IN ASEPTIC TECHNIQUE DUE TO RECONNECTION OF THE TRANSFER SET DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. THIS IS REPORT 1 OF 3 INVOLVED IN THIS PERITONITIS EVENT. ON AN UNREPORTED DATE "LESS THAN ONE YEAR AGO" THE PT BEGAN TREATMENT WITH DIANEAL AMBUFLEX THERAPY (DOSE, FREQUENCY, AND LOT NOT REPORTED) INTRAPERITONEALLY (IP) FOR PD. IT WAS REPORTED THAT THE "CATHETER CAME APART, TRANSFER SET BROKE AND THE PATIENT'S SHIRT WAS SOAKED" WHICH CAUSED PERITONITIS. THE TRANSFER SET WAS RECONNECTED TO THE TITANIUM ADAPTER PRIOR TO TAKING THE PT TO THE CLINIC. ON THE SAME DAY, THE PT WAS SEEN AT THE PD CLINIC AND THE STAFF REPLACED THE PATIENT'S TITANIUM CONNECTOR AND TRANSFER SET WITH NEW SUPPLIES. THE PT WAS NOT HOSPITALIZED FOR THE EVENT. ON THE SAME DAY, THE PT BEGAN TREATMENT FOR THE PERITONITIS WITH VANCOMYCIN, 75 MG/3 LITER PD SOLUTION BAG OF LOW CALCIUM DIANEAL, IP, NIGHTLY, FOR 7 DAYS. AT THE TIME OF THIS REPORT, THE PT WAS RECOVERING FROM THE PERITONITIS. THE CAUSE OF THE DISCONNECTION WAS LATER DESCRIBED AS THE CONNECTION WAS NOT SCREWED ON TIGHT ENOUGH AND BECOME DISCONNECTED. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232388 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 12 MO Required Intervention DIANEAL AMBUFLEX