BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 2822501 · Received November 2, 2012

    Report

    Report Number
    9616026-2012-00004
    Event Type
    Injury
    Date Received
    November 2, 2012
    Date of Event
    September 1, 2012
    Report Date
    October 3, 2012
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRISMAFLEX CONTROL UNIT WAS NOT INSPECTED BY A SERVICE TECH AFTER THE REPORTED EVENT(S). THE TREATMENT DATA CARD FROM THE PRISMAFLEX CONTROL UNIT HAVE BEEN ANALYZED. BASED ON THESE, THERE IS NO INDICATION THAT THE PRISMAFLEX CONTROL UNIT FAILED IN THE REPORTED EVENT(S). THE PRISMAFLEX CONTROL UNIT WITH SW 6.10 INVOLVED IN THIS EVENT DOES NOT HAVE 510(K) CLEARANCE BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (510(K) CLEARANCE K110823).

    Description of Event or Problem · 1

    A PT IN (B)(6) WAS UNDERGOING CRRT FOR APPROX 4 WEEKS. DURING THE COURSE OF THERAPY THE PT EXPERIENCED BLOOD LOSS WHEN THE EXTRACORPOREAL CIRCUIT CLOTTED AND BLOOD WAS NOT RETURNED TO THE PT. GAMBRO HAS RECEIVED LIMITED INFO RELATED TO THE PT'S CONDITION. THE PHYSICIAN REPORTED THAT THE PT HAS BLEEDING ISSUES AND HAD BEEN RECEIVING BLOOD TRANSFUSION FOR HIS UNDERLYING MEDICAL CONDITION. THE PRISMAFLEX CONTROL UNIT WAS NOT INSPECTED FOLLOWING THESE EVENTS AS THE CLINIC DID NOT SUSPECT THAT THE PRISMAFLEX CONTROL UNIT FAILED. ACCORDING TO THE CLINICAL INFO, THE PT HAS BEEN DISCHARGED FROM THE INTENSIVE CARE UNIT AND HAS MOVED TO A CHRONIC DIALYSIS CENTRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX KDI GAMBRO LUNDIA AB 114489

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Other