BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX HF1400

    MDR report key: 7372420 · Received March 26, 2018

    Report

    Report Number
    8010182-2018-00019
    Event Type
    Malfunction
    Date Received
    March 26, 2018
    Date of Event
    February 27, 2018
    Report Date
    April 20, 2018
    Manufacturer
    BAXTER HEALTHCARE - MEYZIEU
    Product Code
    KDI
    UDI-DI
    07332414069315
    PMA / PMN Number
    K042938
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE REPORTER STATED THAT THE DIALYSIS MACHINE HAD PRESENTED A FLOW PROBLEM (EFFLUENT) ALARM AT THE TIME OF THE EVENT. 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; HOWEVER, THE MACHINE WAS REPORTED TO HAVE PRESENTED A FLOW ALARM. SWITCHED PBP AND EFFLUENT LINES ARE A KNOWN CAUSE OF THIS ALARM. THE CAUSE OF THE SWITCHED LINES WAS DETERMINED TO BE AN ASSEMBLY ISSUE DURING THE MANUFACTURING PROCESS. TO ADDRESS THIS ISSUE, THE INVOLVED OPERATOR HAS BEEN RETRAINED AND AWARENESS TRAINING WAS PROVIDED TO ALL OPERATORS. THE REPORTED LOT WAS MANUFACTURED PRIOR TO THIS ACTION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A NURSE REPORTED THAT FLUID WAS BEING PULLED FROM THE PBP BAG EVEN THOUGH THE PBP CIRCUIT ON A PRISMAFLEX HF1400 SET WAS CLAMPED AND THE FLOW RATE WAS SET TO ZERO. TREATMENT WAS TERMINATED WITH BLOOD RETURN. UPON TROUBLESHOOTING, IT WAS FOUND THAT THE EFFLUENT AND PBP LINES HAD BEEN MISASSEMBLED IN THE HF1400 FILTER SET. THE PBP LINE WAS COMING FROM THE LOWER PORTION OF THE EFFLUENT PUMP AND THE EFFLUENT LINE WAS COMING FROM THE UPPER PORTION OF THE PBP PUMP. 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
    215204 PRISMAFLEX HF1400 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MEYZIEU NA 17I0704 07332414069315

    Patients

    Seq Age Sex Outcome Treatment
    1