BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2884086 · Received December 21, 2012

    Report

    Report Number
    1416980-2012-07972
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 30, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A SAMPLE IS NOT REQUIRED FOR USE ERROR AS THERE IS NO ALLEGATION AGAINST THE DEVICE. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, A BATCH REVIEW WAS NOT PERFORMED. THIS REPORT OF USE ERROR, WITH A BREACH IN ASEPTIC TECHNIQUE, WAS CONFIRMED AS THE NURSE REPORTED THERE WAS A BREAK IN ASEPTIC TECHNIQUE. THIS WAS DESCRIBED AS THE PATIENT MAKING A MISTAKE OR HAD TOUCH CONTAMINATION. HOWEVER, THE ASSIGNABLE CAUSE COULD NOT BE DETERMINED. INSTRUCTIONS RELATED TO THE REPORTED PROBLEM ARE CONTAINED IN THE PRODUCT LABELING, ARE ACCURATE AND SUFFICIENT, AND EASILY ACCESSIBLE BY THE PATIENT. NO ISSUES WERE IDENTIFIED WITH THE PRODUCT LABELING THAT WOULD CONTRIBUTE TO THE REPORTED PROBLEM. 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.

    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 PROVIDED BY A NURSE. THIS REPORT IS OF A PATIENT THAT MADE A MISTAKE INVOLVING TOUCH CONTAMINATION AND PERITONITIS, WITH A CULTURE POSITIVE FOR STAPHYLOCOCCUS AND SEVERE CONSTIPATION. THIS OCCURRED IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2012, DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED BY THE PATIENT'S SPOUSE. ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED PERITONITIS. CAUSE OF PERITONITIS WAS UNKNOWN. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT. DIANEAL THERAPIES WERE ONGOING. ON (B)(6) 2012, THE FOLLOWING INFORMATION WAS RECEIVED FROM THE PERITONEAL DIALYSIS NURSE (PDN). ON AN UNREPORTED DATE, PATIENT MADE A MISTAKE OR HAD TOUCH CONTAMINATION. DUE TO WHICH, ON (B)(6) 2012, THE PATIENT EXPERIENCED PERITONITIS. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. HOWEVER, TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT. DIANEAL THERAPIES WERE ONGOING. THE PD NURSE STATED THE PERITONITIS, WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS, WAS UNRELATED TO DIANEAL THERAPY. ON (B)(6) 2012, THE PATIENT'S SPOUSE AGAIN CONTACTED BAXTER CUSTOMER SERVICE AND REPORTED THE FOLLOWING INFORMATION. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED SEVERE CONSTIPATION. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THE SEVERE CONSTIPATION. ON (B)(6) 2012, FURTHER FOLLOW-UP WAS PERFORMED WITH THE PDN REGARDING THE REPORT OF CONSTIPATION. THE FOLLOWING INFORMATION WAS OBTAINED. THE NURSE CLARIFIED THE HOSPITALIZATION WAS FOR PERITONITIS. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION, BECAUSE THE INFORMATION HAD BEEN PREVIOUSLY REPORTED. ON (B)(6) 2012, PRODUCT SURVEILLANCE SPOKE WITH THE PATIENT'S WIFE AND THE FOLLOWING INFORMATION WAS REPORTED. THE WIFE STATED SHE DID NOT KNOW THE CAUSE OF THE PERITONITIS, BUT CONFIRMED SHE AND HER HUSBAND (THE PATIENT) HAD BEEN RETRAINED ON PROPER ASEPTIC TECHNIQUE AT THE CLINIC.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization DIANEAL PD4 AMBUFLEX| HOMECHOICE