BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXTENSION SET

    MDR report key: 2022688 · Received March 17, 2011

    Report

    Report Number
    1423500-2011-03331
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 23, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K925403
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    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 3 OF 5 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED ON POTENTIALLY ASSOCIATED LOT NUMBER H10J13076 WITH NO DEFECTS NOTED. THE COMPLAINT WAS NOT CONFIRMED, BUT DUE TO THE INFORMATION WITHIN THE COMPLAINT 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM THE USA OF A PATIENT WHO MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS COINCIDENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS (PD). DURING A CALL TO BAXTER CUSTOMER SERVICE, THE PATIENT REPORTED THE FOLLOWING. ON (B)(6) 2011 THE PATIENT EXPERIENCED PERITONITIS AND WAS NOT HOSPITALIZED. UPON A FOLLOW UP CALL WITH THE PATIENT?S NURSE, THE NURSE REPORTED THAT IN (B)(6) 2011, THE PATIENT MADE A MISTAKE/TOUCH CONTAMINATION. THE NURSE REPORTED THAT TREATMENT INCLUDED IP ANTIBIOTICS (NAME, DOSE, AND FREQUENCY NOT REPORTED). AT THE TIME OF REPORTING, THE PATIENT WAS RECOVERING FROM THE PERITONITIS AND DIANEAL THERAPIES WERE ONGOING. IT WAS NOT REPORTED IF THE EVENT OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION RESOLVED. THE NURSE REPORTED THAT THE EVENT OF PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS WAS UNRELATED TO DIANEAL THERAPIES. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF PATIENT MISTAKE/TOUCH CONTAMINATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention HOMECHOICE PERITONEAL DIALYSIS CYCLER| DIANEAL PD4 ULTRABAG| DIANEAL PD4 AMBUFLEX