BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2872371 · Received December 13, 2012

    Report

    Report Number
    1416980-2012-07250
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    November 1, 2012
    Report Date
    November 21, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    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 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. A SAMPLE WAS NOT REQUESTED BECAUSE THE EVENT INVOLVED USE ERROR AND THERE WAS NO ALLEGATION AGAINST THE DEVICE. THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE THE NURSE REPORTED A BREAK IN ASEPTIC TECHNIQUE DESCRIBED AS THE PATIENT MADE A MISTAKE AND TOUCH CONTAMINATION OCCURRED. THE ASSIGNABLE CAUSE FOR THE BREAK IN ASEPTIC TECHNIQUE WAS NOT DETERMINED. A LABELING REVIEW WAS PERFORMED WHICH FOUND THE LABELING ADEQUATE FOR THE PREVENTION OF THE USE ERROR IN THIS COMPLAINT. THE LABELING REVIEW CONFIRMED, INSTRUCTIONS RELEVANT TO THE COMPLAINT ARE DOCUMENTED IN THE PRODUCT LABELING AND ARE EASILY ACCESSIBLE TO THE USER. 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 IS A REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE IN THE USA OF PATIENT MADE MISTAKE/TOUCH CONTAMINATION AND PERITONITIS WITH CULTURE (B)(6) IN A PATIENT COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX 1.5% , LOW CALCIUM, DIANEAL PD4 2.5%, LOW CALCIUM, AND DIANEAL 4.25%, LOW CALCIUM AMBUFLEX THERAPIES (DOSES, FREQUENCIES AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING INFORMATION WAS REPORTED BY THE CONSUMER (PATIENT'S WIFE). ON (B)(6) 2012, THE HOME PATIENT (HP) EXPERIENCED PERITONITIS. PER THE REPORTER, THE HP WAS NOT HOSPITALIZED FOR THE EVENT. THE REPORTER REPORTED THE CAUSE OF THE PERITONITIS AS UNKNOWN. THE REPORTER STATED THE HP IS RECOVERING FROM THE PERITONITIS AND PD THERAPY IS ONGOING. ON THE SAME DATE, ADDITIONAL FOLLOW UP INFORMATION WAS RECEIVED FROM THE PD NURSE (PDN). THE PDN CONFIRMED THE REPORT OF PERITONITIS AND THAT THE HP WAS NOT HOSPITALIZED FOR THE EVENT. TREATMENT WAS NOT REPORTED. CONCOMITANT THERAPY WAS NOT REPORTED. THE PDN REPORTED THE CAUSE OF THE PERITONITIS WAS THE PATIENT MADE A MISTAKE AND TOUCH CONTAMINATION OCCURRED (DATE UNSPECIFIED AND DETAILS NOT PROVIDED). ON (B)(6) 2012, BAXTER PRODUCT SURVEILLANCE CONTACTED THE PDN AND RECEIVED THE FOLLOWING ADDITIONAL INFORMATION. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. THE PDN VERIFIED THE PATIENT WAS RE-TRAINED IN ASEPTIC PROCEDURES FOR PD THERAPY. THE PDN CONFIRMED THE CAUSE OF THE PERITONITIS WAS NOT RELATED TO A BAXTER DEVICE OR SOLUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Other DIANEAL PD4 AMBUFLEX 4.25%, LOW CALCIUM| DIANEAL PD4 AMBUFLEX 2.5%, LOW CALCIUM| DIANEAL PD4 AMBUFLEX 1.5%, LOW CALCIUM