BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3182874 · Received June 21, 2013

    Report

    Report Number
    1416980-2013-16168
    Event Type
    Injury
    Date Received
    June 21, 2013
    Date of Event
    May 12, 2013
    Report Date
    May 29, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT FROM A PATIENT OF A HOME PATIENT (HP) THAT EXPERIENCED AIR IN THE TUBING AND REPORTED AN UNSPECIFIED AMOUNT OF AIR IN THE PERITONEAL CAVITY. THE EVENT REPORTEDLY REQUIRED HOSPITALIZATION FOR FOUR DAYS. PER THE HOME PATIENT (HP) THE HP HOOKED UP TO THE MACHINE, WENT TO DRAIN HIMSELF AND WHEN HE OPENED THE EXTENSION LINE TO HIT THE DRAIN LINE, IT ONLY SUCKED A LITTLE BIT. THE CLAMP WAS CLOSED AND SHOULD HAVE STAYED OPEN; THEREFORE, AIR WAS PUSHED INTO THE PATIENT. THE PATIENT SUFFERED SHOULDER PAIN ON THE RIGHT SIDE OF HIS BODY THROUGH THE NIGHT THEN WENT TO THE HOSPITAL IN THE MORNING. THE PATIENT INITIALLY HAD AN EMERGENCY ROOM VISIT BUT THEN WAS ADMITTED FOR FOUR DAYS AND GIVEN UNSPECIFIED PAINKILLERS AS TREATMENT. THE PATIENT HAD TWO BLOOD TRANSFUSIONS, THE HEART RATE (NOT REPORTED) WAS "ALL OVER THE PLACE", THE PATIENT IS NOW FREE FROM PAIN AND NO LONGER HAS AIR IN HIS SYSTEM. PER THE REGISTERED NURSE (RN), THE PATIENT WAS AT ANOTHER HOSPITAL THEREFORE SHE DIDN'T HAVE FURTHER DETAILS. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283714 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL 7.5%| NUTRINEAL PD4 1.1%| PHYSIONEAL 3.86%| PHYSIONEAL 2.27%