BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMAFLEX M100

    MDR report key: 8883510 · Received August 12, 2019

    Report

    Report Number
    8010182-2019-00167
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 11, 2019
    Report Date
    September 18, 2019
    Manufacturer
    BAXTER HEALTHCARE - MEYZIEU
    Product Code
    KDI
    PMA / PMN Number
    K041005
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DEVICE WAS NOT AVAILABLE; HOWEVER, PHOTOGRAPHS OF THE SAMPLE WERE PROVIDED FOR EVALUATION. THE VISUAL INSPECTION OF THE PROVIDED PICTURES SHOWED THAT ONE EXTREMITY OF THE PBP PUMP SEGMENT WAS DISCONNECTED FROM THE SUPPORT PLATE. THE PUMP SEGMENT WAS NOT INSERTED ALL THE WAY IN THE SUPPORT PLATE. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION WAS DETERMINED TO BE A MANUFACTURING ISSUE. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. 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 AFTER APPROXIMATELY ONE HOUR OF TREATMENT WITH A PRISMAFLEX SET AND A PRISMAFLEX CONTROL MACHINE, THE MACHINE ALARMED AN ¿AIR IN BLOOD ¿ AND THEN "GENERAL SYSTEM FAILURE" ALARM. FURTHER OBSERVATION REVEALED THAT THE PBP LINE WAS BROKEN AT THE JUNCTION OF THE PBP LINE AND THE CARTRIDGE. TREATMENT WAS DISCONTINUED AND A NEW SET WAS USED TO COMPLETE TREATMENT WITHOUT A REPORT OF BLOOD RETURN TO THE PATIENT. 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
    679921 PRISMAFLEX M100 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - MEYZIEU NA 19A0201

    Patients

    Seq Age Sex Outcome Treatment
    1 PRISMAFLEX CONTROL UNIT| PRISMAFLEX CONTROL UNIT