BEUDAMED
    FDA Adverse Event Summary report: N

    SIEMENS WATER TREATMENT SYSTEM

    MDR report key: 3771491 · Received April 24, 2014

    Report

    Report Number
    3019131-2014-00017
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    April 24, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR COR PURIFICATION CONFIRMS THAT 2 SHIFTS OF 26 PATIENTS WERE DELAYED BECAUSE THEY DECIDED TO DISINFECT.

    Additional Manufacturer Narrative · 1

    BROKEN RISER IN A DI TANK NECESSITATED A CHANGE IN THE DI TANK. FACILITY CALLED MAR COR PURIFICATION AND MCP TECHNICIANS WERE ON SITE IN UNDER 2 HRS TO REMEDIATE /ADDRESS THE PROBLEM. TANK AND FILTERS CHANGED WITHOUT INCIDENT; HOWEVER, THIS CAUSED DELAY IN PATIENT TREATMENT. 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

    BROKEN RISER IN A DI TANK NECESSITATED A CHANGE IN THE DI TANK. FACILITY CALLED MAR COR PURIFICATION AND MCP TECHNICIANS WERE ON SITE IN UNDER 2 HRS TO REMEDIATE /ADDRESS THE PROBLEM. TANK AND FILTERS CHANGED WITHOUT INCIDENT; HOWEVER, THIS CAUSED DELAY IN PATIENT TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249307 SIEMENS WATER TREATMENT SYSTEM DEIONIZED WATER SYSTEM FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1