BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX HF1400

    MDR report key: 7440684 · Received April 18, 2018

    Report

    Report Number
    8010182-2018-00032
    Event Type
    Malfunction
    Date Received
    April 18, 2018
    Date of Event
    March 21, 2018
    Report Date
    April 18, 2018
    Manufacturer
    BAXTER HEALTHCARE - MEYZIEU
    Product Code
    KDI
    UDI-DI
    07332414069315
    PMA / PMN Number
    K042938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS WAS REPORTED TO BE A PEDIATRIC PATIENT. 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 · 1

    IT WAS REPORTED THAT A PRISMAFLEX HF1400 SET HAD AN AIR LEAK DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT). THE REPORTER STATED THAT CHRONIC ACCESS EXTREMELY NEGATIVE ALARMS OCCURRED ON THE BAXTER DIALYSIS MACHINE SINCE STARTING TREATMENT. INITIALLY, THE ACCESS PRESSURES HAD BEEN IN THE -240'S, EVEN AFTER DECREASING THE BLOOD FLOW RATE (BFR) TWICE. TROUBLESHOOTING WAS PERFORMED WITH THE CUSTOMER. THE CUSTOMER HAD DELAYED THE SELF-TEST; HOWEVER, THE ACCESS PRESSURE WAS VERY POSITIVE AND THE ACCESS PRESSURE POD APPEARED EMPTY. THE CUSTOMER NOTED THAT THERE WAS A GOOD AMOUNT OF AIR IN THE ACCESS AND CITRATE (PBP) LINES. THE CUSTOMER STATED THAT IT LOOKED LIKE THE AIR WAS PULLING FROM THE PATIENT. THE CUSTOMER DECREASED THE BFR FURTHER AND CLEANED THE ACCESS PRESSURE SENSOR HOUSING. THE ACCESS PRESSURE POD FILLED, THE ACCESS PRESSURE WAS NOW IN THE -200'S, AND THE AIR WAS NO LONGER PULLING FROM THE PATIENT. AIR BUBBLES WERE STILL PRESENT IN THE PBP LINE. THE CUSTOMER TRACED THE SOURCE OF THE AIR BUBBLES TO THE CONNECTION BETWEEN THE UPPER PBP LINE AND THE CARTRIDGE/PUMP. THERE WERE NO BUBBLES IN THE PBP LINE BETWEEN THE PBP BAG AND PUMP OR IN THE PBP PUMP SEGMENT. THE CUSTOMER STATED THAT THERE APPEARED TO BE AN AIR LEAK AT THE PBP LINE CONNECTION TO THE CARTRIDGE. THE BLOOD IN THE CIRCUIT WAS RETURNED TO THE PATIENT, AND THE SET WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283637 PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MEYZIEU NA 17L0503 07332414069315

    Patients

    Seq Age Sex Outcome Treatment
    1