BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2840683 · Received November 20, 2012

    Report

    Report Number
    1416980-2012-05675
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 30, 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, FOLLOW UP INFORMATION WAS RECEIVED BY GLOBAL PHARMACOVIGILANCE (GPV) FROM THE NURSE. ON (B)(6) 2012, THE PATIENT EXPERIENCED THE ONSET OF A CATHETER EXIT SITE INFECTION. THE NURSE CLARIFIED THAT THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF DIZZINESS AND THAT THE PATIENT DID NOT HAVE PERITONITIS. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2012 FOR THE EVENTS. ON AN UNREPORTED DATE, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WITH RESULTS (B)(6) CAUSATIVE AGENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EXIT SITE INFECTION. AT THE TIME OF THE REPORT, PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE INFECTION AND THE DIZZINESS. THE CATHETER WAS NOT REMOVED. PER THE NURSE, A DOCTOR HAD CITED THAT THE DIZZINESS MAY HAVE BEEN CAUSED BY AN UNKNOWN ANTI-BIOTIC THERAPY GIVEN FOR THE CATHETER EXIT SITE INFECTION. THE CAUSE OF THE EXIT SITE INFECTION WAS UNKNOWN. PER THE NURSE, THE EVENT WAS UNRELATED TO PD THERAPY. THIS EVENT IS NO LONGER CONSIDERED A PERITONITIS EVENT OR RELATED TO BAXTER PRODUCTS. THEREFORE, NO FURTHER INVESTIGATION WILL BE PERFORMED AND NO FURTHER FOLLOW UP MEDWATCHES WILL BE SENT REGARDING THIS EVENT.

    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. THE SPECIFIC PRODUCT CODE FOR THE MINICAP TRANSFER SET INVOLVED IS UNKNOWN; THEREFORE, D4 IS UNKNOWN. THE BRAND NAME, MANUFACTURE AND 510K HOWEVER HAVE BEEN PROVIDED IN THIS MDR. A BATCH REVIEW WAS CONDUCTED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H12C27078, H12E21068, H12F06075 AND H12B29043 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER IN THE USA. THIS REPORT IS OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE PERITONITIS. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    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 61 YR Hospitalization HOMECHOICE| DIANEAL PD4 AMBUFLEX