BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1960685 · Received January 14, 2011

    Report

    Report Number
    1423500-2011-00595
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 24, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WILL NOT BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV). THIS IS A SOLICITED REPORT BY A CONSUMER WITH INFORMATION BY A PHYSICIAN FROM (B)(6) OF PERITONITIS AND H1N1 INFLUENZA IN A PATIENT COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD) THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A 3-WEEK HISTORY OF FEVER AND LETHARGY; NAUSEA AND VOMITING FOR 10 DAYS. ON (B)(6) 2010, THE PATIENT HAD MILD ABDOMINAL PAIN AND "CLOUDY BAG". THE PATIENT RECEIVED CO-AMOXICLAV 1.5 GRAM TWICE DAILY (GIVEN UNTIL (B)(6) 2010) AS EMPIRICAL THERAPY FOR PYREXIAL ILLNESS. SUBSEQUENTLY, THE PATIENT WAS DIAGNOSED WITH H1N1 INFLUENZA AND WAS ADMINISTERED OSELTAMIVIR 30 MG (SINGLE DOSE) ON (B)(6) 2010 AND 30 MG (SINGLE DOSE) ON (B)(6) 2010. AT THE TIME OF THIS REPORT, THE OUTCOME WAS REPORTED AS ONGOING AND DETERIORATED. PER THE REPORTER, THE PD SOLUTION WAS NOT REINTRODUCED. THE PHYSICIAN CONSIDERED THE EVENT TO BE MODERATE IN SEVERITY AND WAS UNCLEAR OF THE ROOT CAUSE OF THE PERITONITIS. THE PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE PERITONITIS AND THE H1N1 INFLUENZA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RENAL - DISPOSABLE SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention DIANEAL PD1