BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAFLEX SETS (ST)

    MDR report key: 15638905 · Received October 20, 2022

    Report

    Report Number
    8010182-2022-00316
    Event Type
    Injury
    Date Received
    October 20, 2022
    Report Date
    October 20, 2022
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRISMAFLEX ST150 SET HAS BEEN TEMPORARILY APPROVED FOR USE IN THE US UNDER EMERGENCY USE AUTHORIZATION EUA200704 TO DELIVER CRRT TO TREAT PATIENTS IN AN ACUTE CARE ENVIRONMENT DURING THE COVID-19 PANDEMIC. THE DEVICE WAS DISCARDED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED, HOWEVER, BASED ON THE INFORMATION RECEIVE THE CAUSE OF THE REPORTED CONDITION IS USER RELATED. THE FUNCTION OF DIALYSIS IS TO FILTER BLOOD. AS PER PRISMAFLEX ST150 SET INSTRUCTION FOR USE (IFU): ¿SINCE DRUGS CAN PASS THROUGH THE MEMBRANE OF THE FILTER, THE DOSAGE OF ASSOCIATED DRUG TREATMENTS MUST BE ADJUSTED FOR PATIENTS ON CONTINUOUS RENAL REPLACEMENT THERAPY¿. THIS IS A KNOWN EFFECT OF THE DEVICE THAT WOULD HAVE BEEN MITIGATED BY APPROPRIATE DOSAGE ADJUSTMENT OF AMBISOME BY THE CLINICIAN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT EXPERIENCED ¿INEFFECTIVENESS OF TREATMENT FOLLOWING THE ESTABLISHMENT OF AN EXTRA-RENAL PURIFICATION FOLLOWING THE APPEARANCE OF AN ACUTE KIDNEY INJURY" AND INVASIVE CANDIDIASIS. THE PATIENT WAS PERFORMING CONTINUOUS VENO-VENOUS HEMODIAFILTRATION (CVVHDF) USING A PRISMAFLEX ST150. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND TREATED WITH AXEPIM 2G X 2/D, FLAGYL 500 MG X3/D, AMBISOME (5 THEN 3 MG/KG/D (210 MG/D) CONTINUOUSLY AND UNINTERRUPTED FOR 67 DAYS), LASIX, MORPHINE TITRATION AND CORTANCYL 80 MG/D. THE PATIENT WAS INTUBATED AND WAS PROVIDED HEMODYNAMIC SUPPORT WITH NORADRENALINE AND DOBUTAMINE. IT WAS NOT REPORTED IF THE PATIENT RECOVERED OM THE INVASIVE CANDIDIASIS EVENT. NO ADDITIONAL INFORMATION WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2149690 PRISMAFLEX SETS (ST) DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Required Intervention