BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CWP 100 CENTRAL WATER TREATMENT SYSTEM

    MDR report key: 7380115 · Received March 28, 2018

    Report

    Report Number
    3019131-2018-00002
    Event Type
    Injury
    Date Received
    March 28, 2018
    Date of Event
    February 28, 2018
    Report Date
    March 28, 2018
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    UDI-DI
    00817492020733
    PMA / PMN Number
    K974899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A FACILITY REPORTED WHILE A PATIENT CARE TECHNICIAN WAS DISCONNECTING THE ACID CONNECTIONS FROM THE DIALYSIS WALL BOX USED WITH THEIR CWP 100 CENTRAL WATER TREATMENT SYSTEM, THE TECHNICIAN CUT HER HAND ON THE DIALYSIS CHAIR AFTER THE CONNECTOR FITTING RELEASED. THE TECHNICIAN DID NOT NEED STITCHES AND IS REPORTED TO BE DOING FINE. MAR COR REGULATORY AFFAIRS FOLLOWED UP WITH THE FACILITY'S TECHNICAL MANAGER AND HE REPORTED HE HAS SINCE TRAINED THE FACILITY STAFF HOW TO DISCONNECT THE CONNECTIONS FROM THE WALL BOXES TO AVOID HITTING THEIR HANDS WHEN THE CONNECTION FITTING RELEASES. THIS COMPLAINT WILL CONTINUE BEING MONITORED IN THE MAR COR PURIFICATION COMPLAINT HANDLING SYSTEM.

    Description of Event or Problem · 1

    A FACILITY REPORTED WHILE A PATIENT CARE TECHNICIAN WAS DISCONNECTING THE ACID CONNECTIONS FROM THE DIALYSIS WALL BOX USED WITH THEIR CWP 100 CENTRAL WATER TREATMENT SYSTEM, THE TECHNICIAN CUT HER HAND ON THE DIALYSIS CHAIR AFTER THE CONNECTOR FITTING RELEASED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223304 CWP 100 CENTRAL WATER TREATMENT SYSTEM WATER PURIFICATION SYSTEM FOR HEMODIALYSIS FIP MAR COR PURIFICATION 104 H 00817492020733

    Patients

    Seq Age Sex Outcome Treatment
    1 Other