BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1790575 · Received August 10, 2010

    Report

    Report Number
    1423500-2010-02330
    Event Type
    Injury
    Date Received
    August 10, 2010
    Date of Event
    July 16, 2010
    Report Date
    July 19, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR. A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10D26088 AND H10E09503 WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THIS IS THE FIRST OF THREE COMPLAINTS ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ONE LOW CREATININE (CRE) PATIENT RESULT GENERATED BY THE UNICEL DXC 800 PRO SYNCHRON CHEMISTRY ANALYZER. THE CUSTOMER REPEATED THE RESULT ON ANOTHER INSTRUMENT AND PROVIDED A NORMAL RESULT. THE ERRONEOUS RESULT WAS STOPPED FROM BEING REPORTED OUT OF THE LABORATORY BY VALIDATION RULES. PATIENT TREATMENT WAS NOT AFFECTED IN THIS EVENT.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE OF A HOMECHOICE PERITONEAL DIALYSIS PATIENT WHO DEVELOPED PERITONITIS WITH A POSITIVE CULTURE FOR (B)(6). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE REPORTING NURSE STATED THAT THE PATIENT MADE MISTAKE, TOUCH CONTAMINATION OCCURRED AND THE PATIENT DID NOT WEAR A MASK (ONSET DATE NOT REPORTED). ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS AND WAS HOSPITALIZED THE SAME DAY. IN (B)(6) 2010, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED WHICH WAS POSITIVE FOR (B)(6). TREATMENT INFORMATION WAS NOT PROVIDED. IT WAS UNKNOWN WHETHER THE PERITONITIS RESOLVED. PER THE NURSE, THE PERITONITIS WITH CULTURE POSITIVE FOR (B)(6) WAS NOT RELATED TO PERITONEAL DIALYSIS THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R 1.5% 3L/3L DIANEAL2.5% 3L/3L DIANEAL4.25% 3L/3