BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2924313 · Received January 22, 2013

    Report

    Report Number
    1416980-2013-01584
    Event Type
    Injury
    Date Received
    January 22, 2013
    Date of Event
    December 1, 2012
    Report Date
    January 2, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION REPORTED AGAINST THE BAXTER PRODUCT BY THE CUSTOMER; THEREFORE, THE SAMPLE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. THE PRODUCT CODE IS UNKNOWN, THEREFORE 510K NUMBER IS UNKNOWN. THIS COMPLAINT FOR A REPORT OF USE ERROR - BREACH IN ASEPTIC TECHNIQUE IS CONFIRMED, BECAUSE IT WAS REPORTED THAT THERE WAS A BREACH IN ASEPTIC TECHNIQUE; HOWEVER, THE ASSIGNABLE CAUSE CODE COULD NOT BE DETERMINED, SINCE IT IS UNSURE WHY THE PATIENT HAD A BREACH IN ASEPTIC TECHNIQUE. 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 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.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER IN THE USA OF STOMACH VIRUS AND PERITONITIS IN A MALE PATIENT (BORN IN 1964) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES. ON AN UNREPORTED DATE IN (B)(6) 2012, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX THERAPIES (DOSES, FREQUENCIES, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DIANEAL THERAPIES WERE ONGOING. DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED STOMACH VIRUS THAT HE HAD FOR ABOUT 4 DAYS. ON UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS DUE TO STOMACH VIRUS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR PERITONITIS. TREATMENT RENDERED WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. FOLLOW UP INFORMATION FROM THE NURSE: ON (B)(6) 2013, SPOKE TO THE PD NURSE WHO PROVIDED NEW MEDICAL INFORMATION. ON (B)(6) 2012, THE PATIENT EXPERIENCED A STOMACH VIRUS. ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. THE PATIENT WAS HOSPITALIZED (B)(6) 2012. THE NURSE STATED THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS AROUND THE CLOCK WHILE HOSPITALIZED. ON AN UNKNOWN DATE IN (B)(6) 2012 THE PATIENT RECOVERED FROM THE STOMACH VIRUS. ON (B)(6) 2012 THE PATIENT RECOVERED FROM PERITONITIS. THE PD CATHETER WAS NOT REMOVED AND IT DID NOT NEED TO BE REPLACED. DIANEAL THERAPY WAS ONGOING. THE EVENT OF PERITONITIS WAS ALSO DUE TO THE PATIENT NOT WEARING A MASK. THE PATIENT WAS RETRAINED IN PROPER ASEPTIC TECHNIQUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29095 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R DIANEAL PD4 AMBUFLEX