BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2931865 · Received January 28, 2013

    Report

    Report Number
    1416980-2013-02093
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    November 1, 2012
    Report Date
    January 7, 2013
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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

    COMPLAINT NO: (B)(4). THE DEVICE INVOLVED IN THIS INCIDENT WAS UNKNOWN. FOLLOW-UP INFORMATION WAS PROVIDED BY A PD NURSE (PDN), WHO MEDICALLY CONFIRMED THIS CASE. THE NURSE CONFIRMED THAT THE PATIENT WAS DIAGNOSED WITH AND HOSPITALIZED FOR CONGESTIVE HEART FAILURE, CHF. THE CAUSE AND TREATMENT FOR THE CHF WERE UNKNOWN. PER THE NURSE, THE PATIENT WAS ALSO DIAGNOSED WITH PERITONITIS ON THE SAME DAY. IT WAS REPORTED TO HAVE BEEN ACQUIRED FROM AN UNTRAINED HOSPITAL NURSE, WHO WAS NOT USING ASEPTIC TECHNIQUE. ABOUT A WEEK LATER, THE PATIENT BEGAN TREATMENT WITH AZTREONAM, IP, EVERY OTHER DAY FOR THE PERITONITIS. TWO WEEKS LATER, THE AZTREONAM WAS STOPPED AND THE PDN CONFIRMED THAT THE PATIENT HAD RECOVERED FROM THE PERITONITIS. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE CHF. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF THE BREAK IN ASEPTIC TECHNIQUE. PER THE NURSE, THE EVENTS OF PERITONITIS AND CHF WERE UNRELATED TO DIANEAL THERAPY. TWO WEEKS LATER, BAXTER GFS PRODUCT SURVEILLANCE(PS) FOLLOWED UP WITH THE PDN. HOWEVER, THE PDN COULD NOT VERIFY IF THE STAFF MEMBER WAS A NURSE STATING, BUT INSTEAD COULD ONLY STATE THAT THEY WAS A STAFF MEMBER. THE PDN STATED THAT SHE DID NOT KNOW IF THAT NURSE WAS RETRAINED. PER THE PDN NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. THIS CONDITION WAS CONFIRMED, AS IT WAS REPORTED THAT THE PERITONITIS WAS CAUSED BY AN UNTRAINED HOSPITAL STAFF MEMBER, WHO WAS NOT USING PROPER ASEPTIC TECHNIQUE. THE ASSIGNABLE CAUSE WAS A USE ERROR. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. SINCE THE LOT IS UNKNOWN, A BATCH REVIEW COULD NOT BE PERFORMED. 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.

    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. A REVIEW OF ALL BATCH RECORD DOCUMENTS WAS PERFORMED FOR ASSOCIATED LOT NUMBER H12G11099 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE AND NO EXCEPTIONS RELATED TO THE REPORTED CONDITION WERE NOTED. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION FROM A NURSE IN THE USA OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL THERAPY WAS NOT REPORTED. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2012, THE PATIENT EXPERIENCED CONGESTIVE HEART FAILURE AND WAS HOSPITALIZED FOR THE EVENT. PER THE NURSE, THE PATIENT HAD A HISTORY OF CONGESTIVE HEART FAILURE AND IT WAS UNRELATED TO A BAXTER DEVICE, DISPOSABLES, OR SOLUTIONS. ON THAT SAME DAY, THE PATIENT ACQUIRED PERITONITIS FROM BEING HOSPITALIZED FOR THE HEART FAILURE. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT RECOVERED FROM THE PERITONITIS AND CONGESTIVE HEART FAILURE. AN OPINION OF CAUSALITY WAS NOT REPORTED FOR THE EVENT OF PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38124 MINICAP TRANSFER SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other HOMECHOICE| DIANEAL PD4 AMBUFLEX