BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2122805 · Received June 14, 2011

    Report

    Report Number
    1423500-2011-07565
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H11C10067 AND H11A19047 WITH NO EXCEPTIONS OBSERVED RELATED TO THE REPORTED CONDITION. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 3 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2011, THE PATIENT DEVELOPED AND WAS HOSPITALIZED FOR PERITONITIS. THE CONSUMER STATED THE PERITONITIS WAS CAUSED BY A MISTAKE THAT WAS MADE IN THE HOSPITAL THE LAST TIME THE PATIENT WAS HOSPITALIZED. THE NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED AND HOSPITALIZED FOR PERITONITIS MANIFESTED BY ABDOMINAL PAIN. TREATMENT PROVIDED WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. PER THE CONSUMER, ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL AND RECOVERING FROM THE PERITONITIS. PER THE NURSE, THE PERITONITIS WAS UNRELATED TO DIANEAL THERAPY.

    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 57 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE