BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2990416 · Received March 5, 2013

    Report

    Report Number
    1416980-2013-05323
    Event Type
    Injury
    Date Received
    March 5, 2013
    Date of Event
    October 24, 2012
    Report Date
    February 11, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT OF PERITONITIS WAS RECEIVED WITH NO ALLEGED DEVICE MALFUNCTION OR USE ERROR; THEREFORE, A SAMPLE WAS NOT REQUESTED. 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. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4).A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12B08047, H12D27068, H12C27078, H12F20092, H12H07087, H12B29043, H12C30049, H12E29053, H12F28087 AND H12H31095 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS (PD). THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT AND WAS DISCHARGED FROM THE HOSPITAL. LATER, THE PATIENT DEVELOPED DIARRHEA AND HAD A COLONOSCOPY PERFORMED (RESULT WAS NOT REPORTED). THE PATIENT GOT A C-DIFF INFECTION FROM THE COLONOSCOPY THAT CAUSED FURTHER COMPLICATIONS WITH STIFF FINGERS AND ARTHRITIS. THE PATIENT WAS HOSPITALIZED FOR THE C-DIFF INFECTION. THE PATIENT WAS LATER TRANSFERRED TO A REHAB CENTER. TREATMENT FOR THE C-DIFF INFECTION WAS NOT REPORTED. THE DIARRHEA, STIFF FINGERS AND ARTHRITIS WERE CONSIDERED MANIFESTATIONS THE OF C-DIFF INFECTION. PD THERAPIES WERE ONGOING. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENTS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    93507 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R HOMECHOICE, DIANEAL PD4 AMBUFLEX