BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4103302 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32457
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS REPORT INVOLVES THE SAME PATIENT AS IN (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER FURTHER INVESTIGATION, IT WAS DETERMINED THE PERITONITIS EVENT WAS CAUSED BY A CONNECTION ISSUE AND A USE ERROR OF A BREACH IN ASEPTIC TECHNIQUE. THE CONNECTION ISSUE WAS FURTHER DESCRIBED AS THE PATIENT EXPERIENCED AN INTERMITTENT CONNECTION BETWEEN THE PLASTIC ADAPTER AND THE TRANSFER SET. THE USE ERROR OCCURRED WHEN THE PATIENT DID NOT USE ASEPTIC TECHNIQUE TO RECONNECT THE TRANSFER SET. ON AN UNREPORTED DATE, THE PATIENT¿S ADAPTER AND TRANSFER SET WERE REPLACED. THE PERITONITIS EVENT WAS MANIFESTED BY FEVER, CLOUDY EFFLUENT, AND ABDOMINAL PAIN (PREVIOUSLY REPORTED ONLY AS FEVER AND ABDOMINAL PAIN). ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH ORAL CIPRO (750 MG, ONE DOSE) AND ORAL CEFAZOLIN (ONE GRAM, THREE TIMES PER WEEK, DURATION NOT REPORTED) FOR PERITONITIS. THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT WAS DISCHARGED 12 DAYS AFTER ADMISSION TO THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED BACTERIAL PERITONITIS COINCIDENT WITH CONTINOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND FEVER. THE PATIENT WAS TREATED WITH UNSPECIFIED INTRAVENOUS ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED) FOR THE EVENT. TREATMENT WAS ONGOING. IT WAS REPORTED THAT THE PD CATHETER WAS REMOVED AND THE PATIENT WAS PLACED ON HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE PATIENT WAS STILL HOSPITALIZED AND HAD NOT RECOVERED FROM THE EVENT. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE. THIS IS REPORT 1 OF 2 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    583603 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL, HOMECHOICE, MINICAP| GENTAMICIN