BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2011116 · Received March 8, 2011

    Report

    Report Number
    1423500-2011-02867
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 16, 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). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBERS H10G30067, H10H31055 AND H10I30048 WITH NO DEFECTS NOTED. THE CAUSE OF THE PERITONITIS WAS USE ERROR-POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 5 OF 6 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 IN THE USA OF NOT WEARING A MASK AND PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS HOMINIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE CONSUMER REPORTED THAT IN (B)(6) 2011, THE PATIENT DID NOT WEAR A MASK AND DEVELOPED PERITONITIS. THE PATIENT STATED THAT HER BROTHER IN LAW AND ANOTHER MAN WERE IN THE ROOM COUGHING. THE PATIENT WAS TOLD THE CAUSE OF THE PERITONITIS WAS "MOUTH BACTERIA FROM HER BROTHER IN LAW AND ANOTHER MAN" THAT WERE IN THE ROOM WHILE SHE WAS DOING HER EXCHANGE. ON AN UNREPORTED DATE IN (B)(6) 2011, ANTIBIOTICS (NAME UNKNOWN AND DOSE AND FREQUENCY NOT REPORTED) WERE GIVEN TO TREAT THE PERITONITIS AND THE PATIENT RECOVERED. THE PATIENT REPORTED SHE JUST FINISHED HER LAST TREATMENT OF ANTIBIOTICS ONE DAY LAST WEEK. THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED IN PD TECHNIQUE, THEREFORE, THE OUTCOME FOR THE EVENT OF DID NOT WEAR A MASK WAS NOT REPORTED. DIANEAL THERAPIES WERE ONGOING. AN OPINION OF CAUSALITY FOR THE EVENTS OF DID NOT WEAR A MASK AND PERITONITIS WAS NOT REPORTED. THE NURSE BELIEVED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS HOMINIS WAS NOT RELATED TO THE DIANEAL THERAPY.

    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 64 YR Required Intervention DIANEAL PD4 ULTRABAG| HOMECHOICE CYCLER| DIANEAL PD4 AMBUFLEX