BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP DISCONNECT CAP

    MDR report key: 1933505 · Received December 20, 2010

    Report

    Report Number
    1423500-2010-07085
    Event Type
    Injury
    Date Received
    December 20, 2010
    Date of Event
    November 1, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K9725798
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR SUSPECT LOT NUMBER(S) 10E17H25 AND 10G15H25 WITH NO DEFECTS NOTED. 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 THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS PROVIDED BY GLOBAL PHARMACOVIGILANCE: THIS IS A SPONTANEOUS NURSE REPORT FROM THE USA ON (B)(6) 2010 OF AN "OLD INCISION THAT BROKE" AND BACTERIAL PERITONITIS WITH THE CULTURE POSITIVE FOR (B)(6) IN A (B)(6) MALE PATIENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (DOSE, FREQUENCY AND LOT NUMBER NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE NURSE STATED THAT ON AN UNREPORTED DATE IN 2010, THE PATIENT HAD AN "OLD INCISION THAT BROKE." ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. TREATMENT INFORMATION WAS NOT PROVIDED FOR THE EVENTS. DIANEAL THERAPY WAS ONGOING. THE PATIENT WAS RECOVERING FROM THE PERITONITIS. IT WAS NOT REPORTED WHETHER THE EVENT OF AN "OLD INCISION THAT BROKE" RESOLVED. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED. PER THE NURSE, THE EVENT OF BACTERIAL PERITONITIS WITH THE CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY. A CAUSAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF AN "OLD INCISION THAT BROKE" WITH REGARDS TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLEXICAP DISCONNECT CAP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Hospitalization| R DIANEAL PD4 AMBUFLEX