BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1880574 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04822
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). BASED ON THE INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE ERROR - POOR ASEPTIC TECHNIQUE. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR(S) IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CALLED TO GET ASSISTANCE IN ENDING THERAPY EARLY, DURING THE "PRESS GO TO START" PHASE OF THERAPY, IN ORDER TO GO TO A DOCTOR APPOINTMENT. THE HP SAID THAT SHE MANUALLY DRAINED BEFORE ATTEMPTING TO END THERAPY. THE TECHNICAL SERVICE REPRESENTATIVE ASSISTED TO RETRIEVE THE CASSETTE FROM THE HOMECHOICE DEVICE. THE HP STATED THIS WAS HER THIRD TIME WITH PERITONITIS. PER THE NURSE, THE PATIENT HAD TWO SEPARATE CASES OF PERITONITIS (NOT THREE). ONE DIAGNOSED ON (B)(6) 2010 AND ONE DIAGNOSED (B)(6) 2010. THE CAUSE OF THE PERITONITIS IS BELIEVED TO BE TOUCH CONTAMINATION AT THE END OF HER TRANSFER SET. THE CAUSE IS BELIEVED TO BE TOUCH CONTAMINATION BECAUSE THE BACTERIA IDENTIFIED IN BOTH CASES IS STAPH EPIDERMIDIS. THE PATIENT WAS RETRAINED ON ASEPTIC TECHNIQUE AND HAS RECOVERED WITHOUT HOSPITALIZATION IN BOTH CASES. IN (B)(6), THE PATIENT WAS TREATED WITH ANSEF (1GRAM) TO DWELL FOR 8 HOURS AND THEN VANCOMYCIN (1 GRAM) FOR TWICE A WEEK FOR 3 WEEKS. THE SEPTEMBER EPISODE WAS TREATED WITH VANCOMYCIN (1 GRAM) TWICE A WEEK FOR 3 WEEKS (BOTH CASES INTRAPERITONEAL). THIS REPORT ADDRESSES THE PERITONITIS DIAGNOSED IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R