BEUDAMED
    FDA Adverse Event Summary report: N

    SIEMENS RO SYSTEM

    MDR report key: 3771468 · Received April 24, 2014

    Report

    Report Number
    3019131-2014-00016
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR COR TECHNICIAN WAS AT THE FACILITY TO DO A SYSTEM DISINFECT OF THEIR RO SYSTEM. TECH NOTIFIED AND WAS LET INTO THE WATER ROOM BY FACILITY MAINTENANCE PERSONNEL. THIS DISINFECTION OF THE SYSTEM WAS COMPLETED WHEN DIALYSIS NURSE/TECHNICIAN WAS INFORMED OF SYSTEM DISINFECTION BY A FACILITY ENGINEERING TECHNICIAN. DIALYSIS NURSE/ TECHNICIAN WAS UNAWARE OF THIS RO SYSTEM WORK BEING PERFORMED. PATIENT TREATMENT WAS DELAYED. THERE IS NO REPORTED PATIENT INJURY OR OTHER ADVERSE PATIENT IMPACT. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MCP COMPLAINT SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED, THIS CASE WILL BE REVIEWED UPON RECEIPT.

    Description of Event or Problem · 1

    MAR COR TECHNICIAN WAS AT THE FACILITY TO DO A SYSTEM DISINFECT OF THEIR RO SYSTEM. TECH NOTIFIED AND WAS LET INTO THE WATER ROOM BY FACILITY MAINTENANCE PERSONNEL. THIS DISINFECTION OF THE SYSTEM WAS COMPLETED WHEN DIALYSIS NURSE/TECHNICIAN WAS INFORMED OF SYSTEM DISINFECTION BY A FACILITY ENGINEERING TECHNICIAN. DIALYSIS NURSE/ TECHNICIAN WAS UNAWARE OF THIS RO SYSTEM WORK BEING PERFORMED. PATIENT TREATMENT WAS DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249279 SIEMENS RO SYSTEM CENTRAL WATER TREATMENT SYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1