BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2864721 · Received December 10, 2012

    Report

    Report Number
    1416980-2012-06877
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    October 1, 2012
    Report Date
    November 19, 2012
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(4) 2012, ADDITIONAL INFORMATION WAS RECEIVED BY GLOBAL PHARMACOVIGILANCE (GPV) FROM A NURSE AND OTHER HEALTH CARE PROFESSIONAL. ON (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX AND DIANEAL PD4 ULTRABAG THERAPIES FOR PERITONEAL DIALYSIS. ON (B)(6) 2012, THE DISCHARGE INSTRUCTIONS INCLUDED CIPRO BY MOUTH WHICH WAS STOPPED ON (B)(6) 2012. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH MYCAMINE. ON (B)(6) 2012, THE THERAPY WAS STOPPED. ON (B)(6) 2012, THE PATIENT WAS TREATED WITH FLUCONAZOLE. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. THE PATIENT DENIED VOMITING, DIARRHEA, OR CONSTIPATION. THE PATIENT REQUIRED PD CATHETER REMOVAL AND PERMACATH PLACEMENT. SHOULD ADDITIONAL INFORMATION BE RECEIVED, ANOTHER FOLLOW UP MDR WILL BE SENT.

    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. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12C27078 AND NO EXCEPTIONS WERE OBSERVED THAT WERE RELATED TO THE REPORTED CONDITION. 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).ADDITIONAL INFORMATION: THE PROBLEM WAS NOT CONFIRMED, AS NO SAMPLE WAS RETURNED FOR EVALUATION. THEREFORE, NO ASSIGNABLE CAUSE WAS DETERMINED, AS NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED DURING THE REPORT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM THE NURSE IN THE USA OF ABDOMINAL PAIN AND PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AMBUFLEX AND DIANEAL ULTRABAG THERAPY FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE FOLLOWING INFORMATION WAS PROVIDED. ON (B)(6) 2012, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS. PER THE NURSE, THE CAUSE OF THE PERITONITIS MAY HAVE BEEN TOUCH CONTAMINATION BUT SHE COULD NOT CONFIRM IT. THE PATIENT WAS TREATED WITH VANCOMYCIN FOR THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON HOW TO PROPERLY PERFORM PD THERAPY. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2012, THE PATIENT WAS RE-ADMITTED TO THE HOSPITAL FOR ABDOMINAL PAIN AND AN ELEVATED WHITE BLOOD CELL COUNT. THE NURSE CLARIFIED THAT THE INFECTION WAS FUNGAL PERITONITIS. THE CAUSE OF THE FUNGAL PERITONITIS WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT DISCONTINUED DIANEAL THERAPY AND BEGAN DOING HEMODIALYSIS. THE NEXT DAY, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. PER THE NURSE, THE EVENTS WERE UNRELATED TO 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 45 YR Hospitalization| R DIANEAL AMBUFLEX| HOMECHOICE| DIANEAL ULTRABAG