BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1970541 · Received January 25, 2011

    Report

    Report Number
    1423500-2011-01002
    Event Type
    Injury
    Date Received
    January 25, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): BAXTER HAS CONDUCTED BATCH REVIEWS FOR POTENTIALLY ASSOCIATED LOTS ( (H10K12068, H10I30097) AND THERE WERE NO DEFECTS NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE WAS IDENTIFIED AS USE ERROR-POOR ASEPTIC TECHNIQUE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THIS IS REPORT 1 OF 3 ASSOCIATED WITH THIS INCIDENT OF PERITONITIS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS PATIENTS DISCARD SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    DURING A FOLLOW UP CALL ON (B)(4) 2011 FOR HOSPITALIZATION AND ANTIBIOTIC THERAPY REPORTED IN AN UNRELATED ALARM COMPLAINT, THE BAXTER REPRESENTATIVE WAS TOLD THAT THE PATIENT HAS PERITONITIS. ON (B)(4) 2011, BAXTER FOLLOWED UP WITH THE PDRN AND WAS INFORMED THAT THE PATIENT WAS HOSPITALIZED FROM (B)(6) 2010. PD EFFLUENT CULTURES WERE TAKEN AND THE PATIENT WAS DIAGNOSED WITH PERITONITIS. THE PDRN STATED THAT SHE DID NOT RECEIVE AN ORGANISM REPORT FROM THE HOSPITAL AND SHE IS THEREFORE UNAWARE OF THE CULTURE OR BLOOD CELL COUNT RESULTS. THE PATIENT WAS STARTED ON UNKNOWN ANTIBIOTICS DURING HER HOSPITAL STAY AND WAS ORDERED TO HAVE VANCOMYCIN IP UPON DISCHARGE. SHE VERBALIZED THAT THE PATIENT SHOULD HAVE BEEN DONE WITH ANTIBIOTIC THERAPY ON (B)(6) 2010 IF SHE HAD BEEN TAKING IT AS PRESCRIBED. THE PDRN REPORTED THAT PATIENT HAD AN APPOINTMENT TO COME TO THE CLINIC TODAY (B)(6) 2010 BUT SHE DID NOT COME AND SHE HAS NOT SEEN THE PATIENT SINCE (B)(6) 2010 AND CAN'T SAY IF SHE IS IMPROVED OR NOT. PER THE RN, THE PATIENT IS NOT APPROPRIATE FOR HEMODIALYSIS BECAUSE HER VEINS ARE POOR. SHE IS UNSURE IF THE PATIENT'S CONDITION HAS IMPROVED OR IF THE PATIENT HAS BEEN TAKING PD THERAPY AS ORDERED SINCE THE PATIENT HAS MISSED ALL SCHEDULED APPOINTMENTS AT THE CLINIC SINCE DISCHARGE FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R (B)(4), 2.5% LO/CAL 6L DIANEAL| HOME CHOICE CYCLER| (B)(4)- EXTRANEAL ICODEXTRIN 2L/3