BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GRANUFLO ACID CONCENTRATE

    MDR report key: 3192722 · Received June 21, 2013

    Report

    Report Number
    1225714-2013-01159
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    May 23, 2013
    Manufacturer
    FRESENIUS MEDICAL CARE NORTH AMERICA
    Product Code
    KPO
    PMA / PMN Number
    K030497
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENTLY, IT IS UNK WHETHER THE PT WAS ADMINISTERED THE FRESENIUS SALINE. WE ARE FILING THIS MDR AS PART OF A SYSTEM LEVEL REVIEW. BASED ON THE INFO PROVIDED, IT IS UNK HOW THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE POST MARKET CLINICAL DEPARTMENT IS IN THE PROCESS OF REQUESTING MEDICAL RECORDS AND ADD'L CLARIFICATION REGARDING THE REPORTED PT CODE DURING TREATMENT. THE DEVICE WAS NOT RETURNED TO THE MFR FOR PHYSICAL EVAL AND THE FAILURE MODE CANNOT BE CONFIRMED. ADDITIONALLY, PRODUCT IDENTIFIERS HAVE NOT BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE PLANT INVESTIGATION AND CLINICAL INVESTIGATIONS ARE COMPLETED. THIS IS ONE OF 6 MDR'S SUBMITTED TO DOCUMENT THIS REPORT EVENT. PLEASE REFERENCE THE FOLLOWING MDR NUMBERS: 8030665-2013-00391; 1713747-2013-00234; 1713747-2013-99913, 1225714-2013-01159; 2937457-2013-00085.

    Description of Event or Problem · 1

    THE FACILITY BIOMEDICAL TECH CONTACTED TECHNICAL SUPPORT ON (B)(6) 2013 REQUESTING A HEMODIALYSIS MACHINE FUNCTIONAL CHECK. THE FACILITY REQUESTED THIS CHECK FOLLOWING A REPORTED PT CODE DURING TREATMENT. CLINICAL DETAILS OF THE REPORTED PT CODE WERE NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282599 GRANUFLO ACID CONCENTRATE KPO FRESENIUS MEDICAL CARE NORTH AMERICA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R SALINE| BLOODLINES| DIALYZER| 2008T HEMODIALYSIS MACHINE