BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2231716 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11575
    Event Type
    Injury
    Date Received
    September 1, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    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 ON POTENTIALLY ASSOCIATED LOT NUMBERS 11D19H25 AND 11A19H25 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 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 2 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 WITH (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT WAS DIAGNOSED WITH PERITONITIS WHICH RESULTED IN HOSPITALIZATION THAT SAME DAY. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED; HOWEVER, THE CONSUMER AND NURSE REPORTED THAT THE PATIENT HAD FOLLOWED HIS PERITONEAL DIALYSIS PROCEDURE, WORE A MASK, CLEANED THE EXIT SITE, DID NOT REUSE DISPOSABLES, AND HAD NOT MISTAKENLY CAUSED CONTAMINATION DURING THE TIME PRECEDING THE EVENT. TREATMENT FOR THE EVENT WAS NOT REPORTED. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. THERAPY WITH DIANEAL PD4 AMBUFLEX WAS ONGOING. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL PD4 AMBUFLEX THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization DIANEAL PD4 AMBUFLEX