BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMAFLOW

    MDR report key: 19589802 · Received June 21, 2024

    Report

    Report Number
    3011767724-2024-00001
    Event Type
    Malfunction
    Date Received
    June 21, 2024
    Report Date
    June 21, 2024
    Manufacturer
    MANAMED, LLC
    Product Code
    JOW
    UDI-DI
    00850998008003
    PMA / PMN Number
    K160318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PLASMAFLOW DEVICE IS DESIGNED WITH SAFETY FEATURES TO ENSURE USER PROTECTION EVEN IF THE CUFF SLIPS FROM THE CALF TO THE ANKLE. SPECIFICALLY, THE DEVICE IS ENGINEERED TO MAINTAIN SAFE PRESSURE LEVELS REGARDLESS OF CUFF POSITION. THE PRESSURE APPLIED AT THE ANKLE IS CONTROLLED AND WILL NOT EXCEED SAFE LEVELS, ENSURING NO HARM TO THE USER. WHILE THE IDEAL PLACEMENT IS ON THE CALF FOR OPTIMAL EFFICACY, COMPRESSION AT THE ANKLE CAN STILL AID IN PROMOTING BLOOD CIRCULATION AND PREVENTING BLOOD POOLING, THEREBY CONTRIBUTING TO VENOUS RETURN. THE DEVICE IS DESIGNED TO BE EASILY ADJUSTABLE. USERS CAN TIGHTEN OR LOOSEN THE CUFF AS NEEDED TO ENSURE IT STAYS IN PLACE, MINIMIZING THE LIKELIHOOD OF IT SLIPPING TO THE ANKLE. USERS RECEIVE INSTRUCTIONS ON CORRECT PLACEMENT AND OPERATION OF THE DEVICE. IF THE CUFF SLIPS, THEY CAN REPOSITION IT TO THE CALVES WITHOUT RISK OF INJURY OR SIGNIFICANT LOSS OF THERAPEUTIC BENEFIT. THE PLASMAFLOW DEVICE INCORPORATES TWO COMPRESSION MODES TO ACCOMMODATE DIFFERENT RECOVERY NEEDS. THE MODES INCLUDE SLOW INFLATION OR STEP-UP TECHNOLOGY, WHICH ALLOWS THE UNIT TO INCREASE PRESSURE IN SLOWER INCREMENTS. THE REPORTED LACK OF A SEQUENTIAL COMPRESSION VALVE, RESULTING IN SIMULTANEOUS INFLATION RATHER THAN DISTAL-TO-PROXIMAL COMPRESSION, CANNOT BE CONFIRMED. SINCE NO CONTACT INFORMATION WAS PROVIDED FOR THE REPORTER, WE REQUEST THAT ANY FURTHER DETAILS OR OBSERVATIONS BE SHARED DIRECTLY WITH MANAMED. WE TAKE THESE CONCERNS SERIOUSLY AND ARE COMMITTED TO ENSURING THE SAFETY AND EFFICACY OF THE PLASMAFLOW DEVICE. WE WILL PROVIDE UPDATES ON OUR FINDINGS AS MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    ON MAY 21, 2024, MANAMED RECEIVED REPORT MW5155059 FROM FDA'S MEDWATCH PROGRAM. THE REPORT ALLEGES THAT THE PLASMAFLOW DEVICE FAILED TO ISSUE AN ERROR CODE FOR LOW PRESSURE AND DID NOT TURN OFF OR ALARM WHEN THE CUFF SLIPPED TOWARDS THE ANKLE. ADDITIONALLY, THE REPORT STATES THAT, IN COMPARISON TO AN OLDER MODEL USED 6.5 YEARS AGO, THE SUSPECT DEVICE LACKS THE SEQUENTIAL COMPRESSION VALVE. INSTEAD OF PROVIDING DISTAL-TO-PROXIMAL PROGRESSIVE COMPRESSION, THE CURRENT MODEL INFLATES ALL CUFFS SIMULTANEOUSLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1103132 PLASMAFLOW SLEEVE, LIMB, COMPRESSIBLE JOW MANAMED, LLC PF0001 MM21051201 00850998008003

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Disability