BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2841725 · Received November 21, 2012

    Report

    Report Number
    1416980-2012-05704
    Event Type
    Injury
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 29, 2012
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT IS FOR A REPORT OF A USE ERROR - BREACH IN ASEPTIC TECHNIQUE AND PERITONITIS. THE COMPLAINT IS CONFIRMED BECAUSE IT WAS REPORTED AS A BREAK IN ASEPTIC TECHNIQUE BY THE CUSTOMER DESCRIBED AS THEY MADE MISTAKE/TOUCH CONTAMINATION. THE ASSIGNABLE CAUSE FOR THE BREACH 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.

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT RECEIVED BY BAXTER (B)(4) FROM (B)(6) HOSPITAL, PERITONEAL DIALYSIS SISTER (PDS), OF PERITONITIS AND TOUCH CONTAMINATION IN A PATIENT COINCIDENT WITH DIANEAL 1.36% THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL, 1.36% (DOSE, FREQUENCY, AND LOT NOT REPORTED), INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT WAS DIAGNOSED WITH PERITONITIS. PER THE REPORTER, THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. PER THE REPORTER, ON (B)(6) 2012 TREATMENT FOR THE PERITONITIS INCLUDED 2 GMS OF VANCOMYCIN, IP, AS THE PATIENT COMMENCED ON CIPROXIN (500MGS BD). ON DAY 5 OF THE TREATMENT, THE PATIENT RECEIVED ANOTHER DOSE OF 2 GMS, VANCOMYCIN, IP. THIS WAS FOLLOWED BY MAINTENANCE DOSES OF 1GM VANCOMYCIN, IP, AND CIPROXIN, ORALLY, WHICH CONTINUED FOR 2 WEEKS (DATES UNSPECIFIED). PER THE PDS THE CAUSE OF THE PERITONITIS WAS TOUCH CONTAMINATION (DETAILS NOT PROVIDED). THE PDS REPORTED, THE PATIENT IS RECEIVING APD (AUTOMATED PERITONEAL DIALYSIS) TRAINING FOR SETUP OF THE MACHINE (DATES UNSPECIFIED). ALSO BOTH HEALTHCARE ASSISTANT TRAINING AND THE PATIENT TRAINING, IN PROPER ASEPTIC TECHNIQUE FOR PD THERAPY, WILL BE REVIEWED WITH THE PATIENT AS PART OF ONGOING TRAINING. THE PERITONITIS WAS REPORTED TO BE ONGOING AT THE TIME OF THIS REPORT. NO FURTHER INFORMATION WAS PROVIDED AT THIS TIME.

    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 Required Intervention DIANEAL 1.36%