BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRISMAX MACHINES

    MDR report key: 17906747 · Received October 10, 2023

    Report

    Report Number
    9616240-2023-00011
    Event Type
    Injury
    Date Received
    October 10, 2023
    Report Date
    November 10, 2023
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDI
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPON FURTHER INFORMATION, THE CUSTOMER COULD NOT CONFIRM THE DURATION OF USAGE OF THE AUTO EFFLUENT BAG IN HOURS; HOWEVER, THEY DID CONFIRM THE AUTO EFFLUENT BAG WAS NOT USE FOR LONGER THAN 6 DAYS. FURTHERMORE, THERE WAS AN AIR GAP BETWEEN THE AUTO-EFFLUENT OUTLET AND THE FLUID OF THE SINK/DRAIN ¿AS PER INSTRUCTIONS OF USE¿. D4: THE POTENTIAL MACHINES USED DURING THE PATIENT'S INPATIENT STAY WERE "PRODUCT CODE: 955725 WITH SERIAL NUMBER (B)(6) ; PRODUCT CODE: 955725 WITH SERIAL NUMBER: (B)(6); AND PRODUCT CODE: 955558 WITH SERIAL NUMBER: (B)(6)". H10: THE DEVICE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, THE MACHINE WAS EVALUATED ON-SITE BY A BAXTER QUALIFIED TECHNICIAN. THE TECHNICIAN PERFORMED SEVERAL UNSPECIFIED EVALUATIONS OF THE MACHINE AND FOUND THE DEVICE PERFORMED ACCORDING TO PRODUCT SPECIFICATIONS. ALSO, A REVIEW OF A STUDY1 REGARDING IF ANY CONTAMINATES PRESENT ON THE TOILET BOWL/DRAIN COULD TRAVEL UP THE EFFLUENT TUBING AND ACROSS THE CHECK VALVE, WHICH IS IN PLACE TO PREVENT BACK-FLOW OF EFFLUENT AND POTENTIAL CONTAMINATION. THIS STUDY DEMONSTRATED THAT THE MIGRATION OF CONTAMINANTS IN A STAGNANT FLOW CONDITION WERE NOT ABLE TO GET TO AND ACROSS THE CHECK VALVE IN THE DURATION OF THE TEST (9 DAYS). SO, ANY CONTAMINANT ENTERING THE END OF THE DRAIN LINE SHOULD NOT BE ABLE TO WORK BACK UP THE SET TO THE BLOODLINE, EVEN IN A WORST-CASE STAGNANT FLOW CONDITION. ACCORDING TO THE PRISMAX INSTRUCTION FOR USE (IFU): ENSURE THERE IS AN AIR GAP BETWEEN THE AUTO EFFLUENT OUTLET AND THE FLUID OF THE SINK/DRAIN. IN ADDITION: AUTO EFFLUENT ACCESSORY AND AUTO EFFLUENT EXTENSION IS INTENDED FOR SINGLE USE ONLY. REPROCESSING THIS EXTENSION TUBING MAY RESULT IN PATIENT OR USER HAZARD DUE TO CONTAMINATION. AS REPORTED THE USER WAS FOLLOWING THE IFU AND IT IS UNLIKELY THAT A BACTERIA WOULD BE ABLE TO BE TRANSPORTED/MOVED AGAINST THE FLUID FLOW AND ACROSS THE FILTER MEMBRANE INTO THE BLOOD STREAM. IN ADDITION, THERE ARE SPECIFIC ALARMS IF THE EFFLUENT OR EFFLUENT DRAIN PUMP IS NOT MOVING AS COMMANDED OR IF THE FLOW IS MOVING IN A NEGATIVE DIRECTION FOR EITHER OF THOSE PUMPS. THEREFORE, THE REPORTED CONDITION WAS NOT VERIFIED IN ANY OF THE MACHINES REPORTED. A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. 1 UPON ADDITIONAL INFORMATION, KIM YA, LEE SJ, PARK YS, LEE YJ, YEON JH, SEO YH, LEE K. RISK FACTORS FOR CARBAPENEMASE-PRODUCING ENTEROBACTERALES INFECTION OR COLONIZATION IN A KOREAN INTENSIVE CARE UNIT: A CASE-CONTROL STUDY. ANTIBIOTICS (BASEL). 2020 OCT 8;9(10):680.

    Additional Manufacturer Narrative · 0

    B3: EVENT DATE: THE DATE OF THE EVENT WAS REPORTED AS UNKNOWN DATES IN (B)(6) 2023. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED AN UNSPECIFIED QUANTITY OF PATIENTS DEVELOPED CARBAPENEMASE-PRODUCING ENTEROBACTERIACEAE (CPE) BACTERIA WITH A PRISMAX AUTO EFFLUENT SET AND PRISMAX MACHINE DURING CONTINUOUS RENAL REPLACEMENT THERAPY. IT WAS FURTHER REPORTED THE AUTO-EFFLUENT IS USED TO EMPTY THE DIALYSATE FLUIDS OF THE PATIENT AUTOMATICALLY TO AN EVACUATION/DRAINING SYSTEM; HOWEVER, THE REPORTING FACILITY DRAINS THE DIALYSATE FLUIDS INTO THE SINK. THE PATIENTS WERE TREATED WITH UNSPECIFIED ANTIBIOTICS. THE DEVICE WAS NOT AVAILABLE FOR SAMPLE RETURN. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302306 PRISMAX MACHINES DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE CORPORATION NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Unknown Required Intervention AUTO EFFLUENT ACCESSORIES