BEUDAMED
    FDA Adverse Event Summary report: N

    F-801 FRESENIUS RO

    MDR report key: 3900633 · Received June 27, 2014

    Report

    Report Number
    3019131-2014-00023
    Date Received
    June 27, 2014
    Date of Event
    May 16, 2014
    Report Date
    June 27, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K964539
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    MAR COR WAS NOTIFIED THAT THE MOTOR OF AN F801 PORTABLE RO UNIT (MANUFACTURED PRIOR TO 2000) FAILED CAUSING A DELAY IN TREATMENT FOR ONE PATIENT. THE REPORTED F801 FRESENIUS RO UNIT WAS MANUFACTURED PRIOR TO THE YEAR 2000. THE F801 EXPECTED PRODUCT LIFE SPAN IS 7 YEARS. MAR COR PURIFICATION VISUALLY INSPECTED THE F801 UPON RECEIPT OF THE RETURNED MACHINE. IT WAS PHOTOGRAPHED AND DOCUMENTED THAT THE MACHINE WAS COVERED IN CORROSION AND/OR RUST ON ALMOST EVERY SURFACE. THIS EVIDENCE REVEALS THAT THE UNIT WAS NOT MAINTAINED PROPERLY. PLEASE REFERENCE ATTACHED PHOTOS: COMPLAINT (B)(4). THERE ARE NO REPORTS OF PATIENT INJURY OR ILLNESS AS A RESULT OF THE FAILURE. THIS COMPLAINT WILL CONTINUE TO BE MONITORED WITHIN MAR COR PURIFICATION COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    MAR COR WAS NOTIFIED THAT THE MOTOR OF AN F801 PORTABLE RO UNIT (MANUFACTURED PRIOR TO 2000) FAILED CAUSING A DELAY IN TREATMENT FOR ONE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378208 F-801 FRESENIUS RO PORTABLE REVERSE OSMOSIS MACHINE FIP MAR COR PURIFICATION ME12340, F801

    Patients

    Seq Age Sex Outcome Treatment
    1