BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2103515 · Received May 26, 2011

    Report

    Report Number
    1423500-2011-06550
    Event Type
    Injury
    Date Received
    May 26, 2011
    Date of Event
    February 1, 2011
    Report Date
    May 6, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT. THE SAMPLE IS NOT AVAILABLE. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS USE ERROR- POOR ASEPTIC TECHNIQUE. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H10J11054). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. A LABELING REVIEW WAS PERFORMED AND THE LABELING WAS FOUND TO PROVIDE AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR STAPH EPIDERMIDIS COAGULASE NEG STAPH IN A (B)(6) FEMALE PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPY (LOT NUMBER, DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE IN 2011, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2011. TREATMENT WAS NOT REPORTED. THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND THE OUTCOME FOR THE MADE MISTAKE/TOUCH CONTAMINATION WAS NOT REPORTED. DIANEAL THERAPY WAS ONGOING. AN OPINION OF CAUSALITY WAS NOT REPORTED. THE NURSE STATED THE PERITONITIS WAS NOT RELATED TO DIANEAL THERAPY AND WAS DUE TO THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE PATIENT MADE MISTAKE/TOUCH CONTAMINATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE DEVICE