BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO

    MDR report key: 3111342 · Received May 9, 2013

    Report

    Report Number
    3005162618-2013-00006
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 14, 2012
    Report Date
    April 9, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE INFO PROVIDED, NO DEFINITIVE CONCLUSION CAN BE DRAWN. CURRENTLY, MEDICAL RECORDS HAVE NOT BEEN PROVIDED. PRODUCT IDENTIFIERS ARE UNK THEREFORE A MFG REVIEW CANNOT BE PERFORMED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADD¿L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS ALLEGED THAT ON (B)(6) 2012 THE PCT (PATIENT CARE TECH) WAS SPLASHED WITH ¿CONTAMINATED¿ DIALYZER FLUID WHEN DISCONNECTING THE DIALYZER FROM THE DIALYSIS MACHINE. THE PATIENT WAS NOT WEARING PPE (PERSONAL PROTECTIVE EQUIPMENT) AT THE TIME. THE PCT WAS SEEN BY A PHYSICIAN ON (B)(6) 2012. HE WAS TREATED WITH PROPHYLACTIC MEDICATIONS. TRUVADA (ANTI-VIRAL AGENT) AND ONDANSETRON (ANTI-EMETIC), AND WAS REFERRED TO AN INFECTIOUS DISEASE SPECIALIST TO RULE OUT BLOOD BORNE PATHOGENS. HE WAS DISCHARGED FROM CARE ON (B)(6) 2013 WITH NO RESULTING KNOWN DISABILITY AND NO ADD¿L CARE WAS REQUESTED OR RECOMMENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204654 GRANUFLO KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Other