BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMERIWATER MRO PORTABLE RO SYSTEM

    MDR report key: 2693258 · Received August 6, 2012

    Report

    Report Number
    1530185-2012-00001
    Event Type
    Malfunction
    Date Received
    August 6, 2012
    Date of Event
    July 13, 2012
    Report Date
    August 1, 2012
    Manufacturer
    AMERIWATER
    Product Code
    FIP
    PMA / PMN Number
    K111740
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    DEPENDING ON USAGE OF THE DEVICE, A MALFUNCTION MAY NOT OCCUR. HOWEVER, AMERIWATER WILL PROVIDE REPLACEMENT FUSES FOR ALL AFFECTED DEVICES TO PREVENT A MALFUNCTION. AMERIWATER IS SENDING NOTIFICATION TO ALL AFFECTED END USERS (USERS FACILITIES AND DISTRIBUTORS OR BILL TO) BY CERTIFIED MAIL. REPLACEMENT FUSES WILL BE SENT FOR ALL AFFECTED DEVICES FOR FIELD REPLACEMENT (OF THE FUSES). AS A PRECAUTION, THE FUSE HOLDERS WILL ALSO BE REPLACED TO PREVENT FAILURE OF FUSE HOLDER THAT MAY HAVE BEEN COMPROMISED BY THE NONCONFORMANCE. AMERIWATER DEALERS WILL COMPLETE THE REPLACEMENT.

    Description of Event or Problem · 1

    AMERIWATER HAS IDENTIFIED A POTENTIAL PROBLEM WITH THE AMERIWATER PORTABLE RO+ SYSTEM MODEL MROS AND MRO1 WITH SERIAL NUMBERS BETWEEN (B)(4). THE FUSES LOCATED IN THE MOTOR STARTER BOX WERE SPECIFIED BY AMERIWATER TO BE 250 VOLT 15 AMP FUSES. HOWEVER, THE SUPPLIER OF THE MOTOR STARTER BOX MISTAKENLY INSTALLED 32 VOLT FUSES IN THE ASSEMBLY. THIS NONCONFORMANCE WAS NOT DETECTED IN ELECTRICAL TESTING AS THE DEVICE PERFORMS WITHIN ALL SPECIFICATIONS. OVER TIME THE INCORRECT FUSE MAY RESULT IN EXCESSIVE HEAT IN THE FUSE HOLDER EVENTUALLY RESULTING IN FAILURE OF THE DEVICE TO OPERATE. THIS MALFUNCTION IS NOT LIKELY TO RESULT IN DEATH OR INJURY, BUT MAY RESULT IN FAILURE OF THE DEVICE TO PERFORM AS INTENDED. THE MALFUNCTION MAY RESULT IN DELAYED TREATMENT, DOWN TIME, OR USE OF ANOTHER DEVICE. DEPENDING ON USAGE OF THE DEVICE, A MALFUNCTION MAY NOT OCCUR. HOWEVER, AMERIWATER WILL PROVIDE REPLACEMENT FUSES FOR ALL AFFECTED DEVICES TO PREVENT A MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMERIWATER MRO PORTABLE RO SYSTEM HEMODIALYSIS WATER PURIFICATION SYSTEM FIP AMERIWATER MROS AND MR01 S/N 31000 - 31079

    Patients

    Seq Age Sex Outcome Treatment
    1 Other