BEUDAMED
    FDA Adverse Event Summary report: N

    REVERSE OSMOSIS SYSTEM

    MDR report key: 3757604 · Received April 17, 2014

    Report

    Report Number
    3019131-2014-00015
    Date Received
    April 17, 2014
    Date of Event
    April 24, 2013
    Report Date
    April 17, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K030348
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER REPORTED AFTER A CARBON TANK RE-BED THE TECHNICIAN LEFT BYPASSES OPEN AND DID NOT PERFORM A CHLORINE CHECK. THE FACILITY CHECKED FOR CHLORINE THE NEXT MORNING BEFORE USING WATER FOR DIALYSIS AND NOTICED THE DISCREPANCY. DIALYSIS FOR PATIENTS WAS DELAYED.TO DATE, THERE WERE NO REPORTS OF PATIENT INJURY OR OTHER ADVERSE PATIENT IMPACT.THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN THE MCP COMPLAINT SYSTEM. IF ADDITIONAL INFORMATION IS RECEIVED, THIS CASE WILL BE REVIEWED UPON RECEIPT.

    Description of Event or Problem · 1

    CHLORINE CHECK NOT DONE AFTER CARBON RE-BEDDED IN MCP RO MACHINE. PATIENT TREATMENT DELAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235759 REVERSE OSMOSIS SYSTEM BIOPURE PORTABLE RO SYSTEM FIP MAR COR PURIFICATION RO 4400M

    Patients

    Seq Age Sex Outcome Treatment
    1