BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2862403 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06765
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS: H12H13036 , H12I13059, AND H12G27038. NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 INVOLVED IN THIS EVENT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD2 AMBUFLEX THERAPY. DIANEAL THERAPY WAS ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED BLOODY PINK DRAINAGE, SHORTNESS OF BREATH, AND FLUID BUILDUP. ON AN UNREPORTED DATE 10 DAYS PRIOR TO HOSPITALIZATION FOR PERITONITIS, THE PATIENT UNDERWENT UMBILICAL HERNIA REPAIR SURGERY. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS MANIFESTED BY ABDOMINAL PAIN. THE PATIENT WAS STARTED ON ANTIBIOTICS FOR THE PERITONITIS. THE PATIENT EXPERIENCED FLUID BUILD UP IN THE HOSPITAL AND TREATMENT FOR THE FLUID BUILD UP INCLUDED AGGRESSIVE FLUID REMOVAL WITH DIANEAL 4.25% SOLUTION AND THE PATIENT WAS INSTRUCTED TO REDUCE ORAL FLUID INTAKE. THE NURSE COULD NOT CONFIRM IF THE PATIENT EXPERIENCED PERITONITIS. IT WAS UNKNOWN IF THE FIRST CULTURE WAS SIGNIFICANT FOR PERITONITIS AS THE NURSE DID NOT HAVE THE RESULTS FROM THE HOSPITAL. THESE EVENTS WERE CONSIDERED TO BE A RESULT OF RECENT UMBILICAL HERNIA REPAIR SURGERY AND LACK OF FLUID CONTROL. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THE OUTCOME OF HERNIA REPAIR WAS NOT REPORTED. THE EVENT OF PERITONITIS WAS UNRELATED TO BAXTER PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R DIANEAL PD2 AMBUFLEX