BEUDAMED
    FDA Adverse Event Death Summary report: N

    PRISMAFLEX SETS (HF)

    MDR report key: 16980360 · Received May 22, 2023

    Report

    Report Number
    8010182-2023-00169
    Event Type
    Death
    Date Received
    May 22, 2023
    Date of Event
    June 22, 2022
    Report Date
    July 24, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    K042938
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ADDED TO B5, B7, D1, D4, D10, G4, H6 AND H10. B5: UPON FOLLOW UP IT WAS REPORTED THE EVENT OCCURRED WHILE USING A PRISMAX MACHINE AND A PRISMAFLEX HF1000 SET (PREVIOUSLY REPORTED AS UNKNOWN). THE ACCESS CATHETER LINE DISCONNECTED FROM THE PORT WHEN THE PATIENT WAS GETTING READY TO ATTEND A PHYSICAL THERAPY SESSION. AT THE TIME OF THE EVENT, THE PATIENT HAD BEEN IN THE HOSPITAL FOR 3-4 WEEKS TO RECOVER FROM ANOTHER INDICATION. D1: BRAND NAME: PRISMAFLEX SETS (HF) D4: CATALOGUE #: 107140; D4: LOT #: 21K0109; D10: CONCOMITANT PRODUCT: PRISMAX MACHINE; G4: PMA/510K #: K042938. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) USING AN UNSPECIFIED PRISMAFLEX SET AND AN UNSPECIFIED BAXTER CRRT MACHINE, A LINE BECAME DISCONNECTED. IT WAS ALLEGED THERE WAS FAILURE TO ADEQUATELY SECURE THE PATIENTS LINES. THE PATIENT REPORTEDLY DEVELOPED AN AIR EMBOLISM AND LOST CONSCIOUSNESS. IT WAS ALLEGED THE CRRT MACHINE FAILED TO SHUT DOWN TO PROTECT THE PATIENT FROM THE EMBOLISM. THE REPORTER STATED EVERY EFFORT WAS MADE TO AID IN THE PATIENT¿S RECOVERY. EIGHT DAYS LATER, THE PATIENT REPORTEDLY DIED DUE TO HYPOXIC ISCHEMIC BRAIN INJURY. ATTEMPTS ARE ONGOING TO OBTAIN THE DEVICE HISTORY LOGS, SERIAL NUMBER AND DEVICE FOR FURTHER EVALUATION. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    471945 PRISMAFLEX SETS (HF) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA 21K0109

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male Death PRISMAX MACHINE| UNSPECIFIED CRRT MACHINE