BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1799794 · Received August 13, 2010

    Report

    Report Number
    1423500-2010-02499
    Event Type
    Injury
    Date Received
    August 13, 2010
    Date of Event
    July 22, 2010
    Report Date
    July 30, 2010
    Manufacturer
    UNKNOWN MANUFACTURING FACILITY
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY NECESSARY SUPPLEMENTAL INFORMATION BECOME AVAILABLE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR, BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME.

    Description of Event or Problem · 1

    A PHYSICIAN FROM (B)(6) CONTACTED BAXTER TO REPORT AN INCIDENT OF PERITONITIS IN AN APPROXIMATELY (B)(6) FEMALE PATIENT ON CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE DOCTOR ALSO REPORTED THE USE OF FAN WHEN PD SOLUTION WAS EXCHANGED. ON (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG. ON AN UNREPORTED DATE, THE PATIENT USED A FAN DURING PERITONEAL DIALYSIS (PD) EXCHANGES. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS, MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN, REQUIRING HOSPITALIZATION THE SAME DAY. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH PAROLADIN 1G X 1G/DAY. ON (B)(6) 2010, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND HAD RECOVERED FROM THE EVENT OF PERITONITIS ON AN UNREPORTED DATE. IT WAS NOT REPORTED WHETHER THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE, THEREFORE THE OUTCOME OF THE EVENT OF USE OF FAN WHEN EXCHANGING PD SOLUTION WAS UNKNOWN. THE ROOT CAUSE OF THE EVENT OF PERITONITIS WAS USE OF FAN WHEN EXCHANGING PD SOLUTION. DIANEAL THERAPY WAS ONGOING. THE PATIENT WAS NOT ON CONCOMITANT MEDICATIONS AT THE TIME OF THE EVENTS. THE REPORTER BELIEVED THE EVENT OF PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY, HOWEVER DID NOT PROVIDE AN OPINION OF CAUSALITY REGARDING USE OF FAN WHEN EXCHANGING PD SOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ UNKNOWN MANUFACTURING FACILITY

    Patients

    Seq Age Sex Outcome Treatment
    1 12