BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2830262 · Received November 13, 2012

    Report

    Report Number
    1416980-2012-04961
    Event Type
    Injury
    Date Received
    November 13, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE ROOT CAUSE COULD NOT BE DETERMINED, SINCE IT IS UNCERTAIN WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. A LABELING REVIEW WAS COMPLETED AND DETERMINED THAT THE INSTRUCTIONS PROVIDE SUFFICIENT LEVEL OF DETAIL ON PREVENTING USE ERROR - BREACH IN ASEPTIC TECHNIQUE. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE IN (B)(6) OF BREAK IN ASEPTIC TECHNIQUE AND PERITONITIS COINCIDENT WITH PHYSIONEAL AND EXTRANEAL THERAPIES. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS MANIFESTED BY CLOUDY EFFLUENT AND ABDOMINAL PAIN. REMEDIAL TREATMENT WITH CEFTAZIDIME INTRAPERITONEALLY (IP) 1G/DAY AND CEFAZOLIN IP 1G/DAY (BOTH ADMINISTERED DURING THE NIGHT CYCLE) WAS INITIATED AND ONGOING. THE EVENT DID NOT REQUIRE HOSPITALIZATION. PERITONEAL DIALYSIS (PD) THERAPY CONTINUED UNCHANGED. ON (B)(6) 2012, THE PATIENT VISITED THE HOSPITAL AND THE PERITONEAL EFFLUENT WAS LIMPID. AT THE TIME OF THIS REPORT THE PERITONITIS WAS ONGOING BUT RESOLVING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention PHYSIONEAL| B-COMPLEX| EXTRANEAL| FOLIC ACID| NEBIVOLOL| ETALPHA| COVERSYL (PERINDOPRIL)| OSVAREN| ERYTHROPOIETIN| OMEPRAZOLE