BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXICAP

    MDR report key: 2220190 · Received August 23, 2011

    Report

    Report Number
    1423500-2011-11086
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    November 1, 2010
    Report Date
    August 2, 2011
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K972579
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS 10F15H25 AND NO EXCEPTIONS WERE OBSERVED THAT WERE 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 2 OF 5 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 NURSE WITH SUPPLEMENTAL INFORMATION BY A CONSUMER FROM THE USA OF NOT GOOD HAND WASHING OR CLEANING TRANSFER SET AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. THE NURSE STATED THAT ON UNREPORTED DATES, THE PATIENT WAS NOT GOOD AT HAND WASHING OR CLEANING THE TRANSFER SET. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT, AND WAS STARTED ON UNSPECIFIED IP ANTIBIOTICS THAT SAME DAY FOR TREATMENT. ON (B)(6) 2010, THE PERITONITIS RESOLVED. THE OUTCOME OF NOT GOOD HAND WASHING OR CLEANING TRANSFER SET WAS NOT REPORTED. IT WAS UNKNOWN WHETHER DIANEAL PD4 ULTRABAG THERAPY WAS ONGOING. THE NURSE DID NOT COMMENT ON CAUSALITY FOR THE EVENT NOT GOOD HAND WASHING OR CLEANING TRANSFER SET, BUT STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL PD4 ULTRABAG 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 72 YR Required Intervention DIANEAL PD4 ULTRABAG| HOMECHOICE