BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX

    MDR report key: 1912374 · Received November 5, 2010

    Report

    Report Number
    9616026-2010-00013
    Event Type
    Injury
    Date Received
    November 5, 2010
    Date of Event
    July 31, 2010
    Report Date
    October 8, 2010
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K072093
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    A HOSP BIOMEDICAL ENGINEER INSPECTED THE PRISMAFLEX MACHINE. HE COULD NOT REPRODUCE THE PROBLEMS REPORTED AND FOUND THE PRISMAFLEX TO BE OPERATING ACCORDING TO THE MFR'S SPECIFICATION. THE PRISMAFLEX WAS RETURNED TO SERVICE. IN THE LATER, PRISMAFLEX SOFTWARE VERSIONS SW VERSION 4.00/5.10 IMPROVEMENTS WERE MADE TO ADDRESS THE CAUSE OF THE MEMORY ERROR CODE 6 ALARMS. THE SOFTWARE VERSION 4.00/5.10 IS PENDING FDA APPROVAL, K083775, SUBMITTED (B)(6), 2008.

    Description of Event or Problem · 1

    WHILE THE PATIENT WAS RECEIVING CONTINUOUS VENOVENOUS HEMOFILTRATION, THE NURSE WAS ATTEMPTING TO ADJUST THE PATIENT FLUID REMOVAL RATE WHEN THE PRISMAFLEX TOUCH SCREEN BECAME UNRESPONSIVE AND THE MACHINE GENERATED "MALFUNCTION: MEMORY ERROR (6)" ALARMS. THE NURSE WAS UNABLE TO HAND CRANK THE BLOOD IN THE CIRCUIT BACK TO THE PATIENT. THE BLOOD IN THE EXTRACORPOREAL CIRCUIT WAS NOT RETURNED TO THE PATIENT AND AS A RESULT THE PATIENT SUSTAINED A BLOOD LOSS OF 186 ML. THE PATIENT RECEIVED A TRANSFUSION OF 1/2 UNIT OF PACKED RED BLOOD CELLS. NO FURTHER CLINICAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMAFLEX KDI GAMBRO LUNDIA AB 107493

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention PRISMAFLEX HF1400 FILTER SET