BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX M100

    MDR report key: 9324763 · Received November 14, 2019

    Report

    Report Number
    8010182-2019-00204
    Event Type
    Malfunction
    Date Received
    November 14, 2019
    Date of Event
    October 21, 2019
    Report Date
    November 9, 2021
    Manufacturer
    BAXTER HEALTHCARE - MEYZIEU
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADVERSE EVENT PROBLEM AND ADDITIONAL NARRATIVE. 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.

    Additional Manufacturer Narrative · 0

    H10: A REVIEW OF COMPLAINTS REPORTING AIR INGRESS INTO THE PRISMAFLEX SETS WAS MADE AS PART OF A HEALTH HAZARD ASSESSMENT RELATED TO A SIMILAR HAZARDOUS SITUATION. THE REVIEW CONCLUDED THAT THE RISK OF INFECTION DUE TO AIR INGRESS IS UNLIKELY AND NO CASES OF INFECTION HAS BEEN REPORTED FOR THIS OR SIMILAR TYPES OF HAZARDOUS SITUATIONS. THEREFORE, THE REPORTED EVENT DOES NOT HAVE THE LIKELIHOOD TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING CONTINUOUS VENO-VENOUS HEMODIAFILTRATION, AIR WAS NOTED IN THE PRE-BLOOD PUMP (PBP) LINE OF THREE PRISMAFLEX SETS AND UPON CLOSER INSPECTION, IT WAS IDENTIFIED THAT THE AIR BUBBLES APPEARED TO BE ORIGINATING IN THE PBP PUMP SEGMENT WHERE THE PBP LINE EXITS THE CARTRIDGE FROM THE PBP PUMP. THE CUSTOMER TAPPED THE LINE AND THE BUBBLES PROGRESSED THROUGH THE LINE, HOWEVER, AIR BUBBLES WERE CONTINUOUSLY BEING PRODUCED FROM WHERE THE PBP LINE CONNECTS TO THE CARTRIDGE AND EXITS THE PUMP. THERE WERE NO BUBBLES IN THE PBP BAG OR IN THE LINE FROM THE PBP BAG TO THE 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
    1115290 PRISMAFLEX M100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MEYZIEU NA 19E0304

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PRISMAFLEX MACHINE