BEUDAMED
    FDA Adverse Event Summary report: N

    Z-9600 RO

    MDR report key: 3793913 · Received May 6, 2014

    Report

    Report Number
    3019131-2014-00020
    Date Received
    May 6, 2014
    Date of Event
    December 23, 2011
    Report Date
    May 6, 2014
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K964539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE STATES THE FACILITY CLINICAL MANAGER INSTRUCTED STAFF MEMBERS TO USE RO WATER TO MAKE COFFEE. THE RO WATER CONSUMED BY 4 PEOPLE CONTAINED MINNCARE COLD STERILANT. THE POTENTIAL CAUSE WAS THAT A VALVE ON THE RO MACHINE WAS LEFT OPEN FROM WHEN IT WAS DISINFECTED THE NIGHT BEFORE. MAR COR PURIFICATION SPOKE WITH THE FACILITY AND SUGGESTED THEY USE A SIGN TO BE PUT ON THE RO MACHINE WHEN DISINFECTION IS BEING PERFORMED. IN ADDITION, IT WAS SUGGESTED THAT PERSONELL THAT INTERACT WITH THIS MACHINE, OTHER THAN THE BIOMEDICAL STAFF, SHOULD BE TRAINED APPROPRIATELY. THE RO MACHINE WAS OPERATING ACCORDING TO SPECIFICATIONS. THIS WAS AN ISOLATED SITE SPECIFIC INCIDENT. THE PERSONELL WHO INGESTED THE MINNCARE PRODUCT DID NOT SUFFER ANY SIDE EFFECTS, ILLNESS OR INJURY AS A RESULT. MAR COR WILL CONITNUE TO MONITOR THIS COMPLAINT.

    Description of Event or Problem · 1

    FACILITY CLINICAL MANAGER INSTRUCTED THE STAFF TO USE RO WATER TO MAKE COFFEE DUE TO FACILITY'S EXPENSES ON BOTTLED WATER. THE RO WATER CONSUMED BY 4 PEOPLE CONTAINED MINNCARE COLD STERILANT DUE TO A VALVE LEFT OPEN ON THE RO MACHINE FROM WHEN IT WAS DISINFECTED THE NIGHT BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270551 Z-9600 RO REVERSE OSMOSIS MACHINE FIP MAR COR PURIFICATION

    Patients

    Seq Age Sex Outcome Treatment
    1 MINNCARE COLD STERILANT