BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLASMAFLOW

    MDR report key: 21434226 · Received February 21, 2025

    Report

    Report Number
    3011767724-2025-00002
    Event Type
    Malfunction
    Date Received
    February 21, 2025
    Date of Event
    October 10, 2024
    Report Date
    February 20, 2025
    Manufacturer
    MANAMED
    Product Code
    JOW
    PMA / PMN Number
    K160318
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION INTO THE REPORTED ISSUE WITH THE PLASMAFLOW DEVICE IS ONGOING. AT THIS TIME, THE DEVICE HAS NOT BEEN RETURNED DESPITE A REQUEST FOR ITS RETURN. A FOLLOW-UP INTERVIEW IS PLANNED WITHIN THE NEXT 60 DAYS. FURTHER UPDATES WILL BE PROVIDED AS MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE PLASMAFLOW DEVICE (MODEL: PF0001, LOT #101301, (B)(6) WAS REPORTED TO HAVE OVERHEATED DURING USE, CAUSING A BURN MARK ON THE PATIENT'S LEG IN THE SHAPE OF THE BATTERY PACK. THE PATIENT USED THE PLASMAFLOW DEVICE FOR 14 DAYS POST-SURGERY BEFORE REPORTING THAT THE DEVICE OVERHEATED AND CAUSED A VISIBLE BURN INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1706614 PLASMAFLOW INTERMITTENT COMPRESSION SLEEVE JOW MANAMED PF0001 PO-101301

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Other