BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT. DL

    MDR report key: 1930187 · Received November 9, 2010

    Report

    Report Number
    8030665-2010-00037
    Event Type
    Death
    Date Received
    November 9, 2010
    Date of Event
    August 6, 2009
    Report Date
    November 9, 2010
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    MA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6); (B)(4)..

    Description of Event or Problem · 1

    (B)(4): PT DIAGNOSED WITH PERITONITIS, SEPTIC INFECTION AND ULTIMATELY DIED. SOMETHING SHOULD HAVE BEEN DONE SOONER. OF NOTE: IT WAS LEARNED THAT THE PT HAD AN EVENT OF PERITONITIS IN 2009. REPORTEDLY FOR THAT EVENT, THE PT CAME INTO THE CLINIC ON (B)(6) 2009. THE PT HAD REPORTED HAVING SOME ABDOMEN PAIN AND CLOUDY EFFLUENT ON THE PREVIOUS DAY. IT WAS DOCUMENTED THAT SLIGHT CLOUDINESS WAS NOTED AND THAT CURRENTLY THE PT DENIED PAIN. CULTURES WERE OBTAINED AND THE PT WAS TREATED WITH ANTIBIOTICS. ADDITIONALLY, ASEPTIC TECHNIQUE WAS REVIEWED AND DEMONSTRATED. ADDITIONALLY, THERE IS NO MENTION OF ANY SORT OF PROBLEM ASSOCIATED WITH THIS PRODUCT. THEN ON (B)(6) 2009, IT WAS NOTED THAT THE CATHETER EXIT SITE WAS CLEAN AND INFECTION FREE. IT WAS ALSO REPORTED THAT THE PT RECOVERED FROM THIS INCIDENT AND CONTINUED HIS PERITONEAL DIALYSIS AS PRESCRIBED. THE PT DID HAVE AN EPISODE ON (B)(6) 2009 OF WHERE HE WAS NOTED TO FEEL DIZZY. IT APPEARS TO BE CARDIAC RELATED. IT WAS LEARNED THAT THE PT WAS EVENTUALLY ADMITTED TO A SKILLED LONG TERM CARE FACILITY ON (B)(6) 2010. IT WAS REPORTED THAT THE PT CONTINUED PERITONEAL DIALYSIS, HOWEVER, A DIFFERENT BRAND OF PERITONEAL DIALYSIS TREATMENT WAS USED. IT WAS LEARNED THAT THE SUBJECT DIED ON (B)(6) 2010. ATTEMPTS HAVE BEEN MADE FOR ADDITIONAL INFO. HOWEVER, TO DATE NO FURTHER INFO HAS BEEN MADE AVAILABLE. THERE IS NO SAMPLE AND THE LOT IS UNK. IT APPEARS THAT THE PT WAS NOT USING THIS PRODUCT AT THE TIME OF HIS DEATH. THE INITIAL REPORTER OF THIS EVENT WAS CONTACTED FOR INFO, BUT DECLINED TO REPORT ANY INFO. IT IS NOT KNOWN IF THE PT HAD PERITONITIS AT THE TIME OF HIS DEATH. THE ACTUAL CAUSE OF THE SUBJECTS DEATH IS UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIBERTY CYCLER SET, SINGLE CONN./EXT. DL PERITONEAL DIALYSIS TREATMENT SET FKX REYNOSA MANUFACTURING NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death LIBERTY CYCLER PERITONEAL DIALYSIS MACHINE