BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2252106 · Received September 16, 2011

    Report

    Report Number
    1423500-2011-12347
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 31, 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). 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 3 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10K29039, H11B07024, H11D12038 AND H11F20093 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED. 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM THE USA OF A PATIENT WHO DID NOT WEAR A MASK AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT DID NOT WEAR A MASK. TREATMENT AND OUTCOME WERE NOT REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR THAT EVENT ON (B)(6) 2011. ON (B)(6) 2011, THE NURSE CONFIRMED THE DIAGNOSIS, START DATE, DATE OF ADMISSION, RECOVERY STATUS AND ONGOING PD THERAPY AS PREVIOUSLY REPORTED BY THE CONSUMER. ON AN UNREPORTED DATE IN 2011, A PERITONEAL EFFLUENT CULTURE WAS OBTAINED. THE RESULTS SHOWED NO GROWTH. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH CEFAZOLIN AND CEFTRIAXONE. THE NURSE COULD NOT CONFIRM THE CAUSE OF THE PERITONITIS AS PREVIOUSLY REPORTED BY THE CONSUMER. THE CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2011, THE PATIENT WAS DISCHARGED. DIANEAL THERAPY WAS ONGOING. THE NURSE REPORTED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL THERAPY BUT DID NOT COMMENT ON THE EVENT OF DID NOT WEAR A MASK.

    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 52 YR Hospitalization| R DIANEAL PD4 AMBUFLEX| HOMECHOICE