BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLEX

    MDR report key: 3746560 · Received April 11, 2014

    Report

    Report Number
    9616026-2014-00007
    Event Type
    Death
    Date Received
    April 11, 2014
    Date of Event
    March 13, 2014
    Report Date
    April 11, 2014
    Manufacturer
    GAMBRO LUNDIA AB
    Product Code
    KDI
    PMA / PMN Number
    K110823
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THERE IS NO INFORMATION INDICATING THAT THE PRISMAFLEX CONTROL UNIT WAS INSPECTED BY A GAMBRO TECHNICIAN OR ANY OTHER TECHNICIAN AFTER THE REPORTED EVENT. THE ANALYSIS OF THE TREATMENT DATA DOWNLOADED FROM THE PRISMAFLEX CONTROL UNIT DOES NOT INDICATE ANY DEVIATIONS OR MALFUNCTION. THE CAUSE OF DEATH IS UNKNOWN BUT IS MOST LIKELY RELATED TO THE PATIENT'S UNDERLYING MEDICAL CONDITION. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT ANY GAMBRO PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE PRISMAFLEX CONTROL UNIT WITH SW 6.10 INVOLVED IN THIS EVENT WHICH OCCURRED IN THE (B)(6) DOES NOT HAVE 510 (K) CLEARANCE BUT IS SIMILAR TO PRISMAFLEX CONTROL UNIT SW 5.10 (510(K) CLEARANCE K110823). GAMBRO DOES NOT REGARD THE SUBMITTAL OF THIS REPORT AS AN ADMISSION OF CAUSATION OR LIABILITY.

    Description of Event or Problem · 1

    A PATIENT HAD A CARDIAC ARREST AND PASSED AWAY WHEN UNDERGOING A CVVHDF TREATMENT ON A PRISMAFLEX CONTROL UNIT. LIMITED TREATMENT- AND PATIENT DATA HAS BEEN PROVIDED. THE MEDICAL STAFF AT THE CLINIC DID STATE THAT THE PATIENT OUTCOME HAD NOTHING TO DO WITH THE DIALYSIS TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    220007 PRISMAFLEX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI GAMBRO LUNDIA AB 114489 (SW 6.10)

    Patients

    Seq Age Sex Outcome Treatment
    1 Death