BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX M150

    MDR report key: 8854544 · Received August 2, 2019

    Report

    Report Number
    8010182-2019-00161
    Event Type
    Malfunction
    Date Received
    August 2, 2019
    Date of Event
    July 10, 2019
    Report Date
    July 21, 2021
    Manufacturer
    BAXTER HEALTHCARE - MEYZIEU
    Product Code
    KDI
    UDI-DI
    07332414090005
    PMA / PMN Number
    K080519
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: REMOVAL OF INFORMATION IN SECTION F RELATED TO IMPORTER - THE INITIAL REPORT INADVERTENTLY INCLUDED THE IMPORTER REPORT NUMBER. THIS MDR SHOULD HAVE BEEN SUBMITTED ONLY WITH THE MFR. NUMBER (AND NOT AS IMPORTER).

    Additional Manufacturer Narrative · 0

    CORRECTION INFORMATION ADDED. UPON FURTHER INVESTIGATION IT WAS DETERMINED THAT AIR BUBBLES PRESENT IN THE EXTRACORPOREAL CIRCUIT DOES NOT HAVE THE LIKELIHOOD TO CAUSE OR CONTRIBUTE TO DEATH OR SERIOUS INJURY IF TO RECUR. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(6). 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 AND THE ROOT CAUSE REMAINS UNKNOWN. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TREATMENT WITH A PRISMAFLEX M150 SET, AIR BUBBLES WERE OBSERVED IN THE PBP LINE. AIR IN BLOOD ALARM WAS TRIGGERED. THE AIR BUBBLES APPEARED TO ORIGINATE IN THE PBP PUMP SEGMENT, WHERE THE PBP LINE ENTERS THE CARTRIDGE TO THE PBP PUMP. IT WAS STATED THAT THERE WAS NO AIR PRESENT IN THE PBP LINE BETWEEN THE PBP BAG AND THE PUMP. THE PATIENT WAS CONNECTED TO THE DEVICE. BLOOD WAS NOT RETURNED TO THE PATIENT. NO ADVERSE EVENT AND MEDICAL INTERVENTION WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    648304 PRISMAFLEX M150 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MEYZIEU NA 19C2701 07332414090005

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISMAFLEX MACHINE