BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPURE HX2

    MDR report key: 5199139 · Received November 3, 2015

    Report

    Report Number
    3019131-2015-00005
    Event Type
    Malfunction
    Date Received
    November 3, 2015
    Date of Event
    October 4, 2015
    Report Date
    March 4, 2016
    Manufacturer
    MAR COR PURIFICATION
    Product Code
    FIP
    PMA / PMN Number
    K133149
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW UP TO 3019131-2015-00005. THE PHASE B FUSE FAILED, LEADING TO THE BREAKDOWN/ELECTRICAL FIRE IN THE HEATER CONTROLLER FUSE HOLDER. THE 180OHM OF RESIDUAL RESISTANCE BETWEEN THE POLES OF THE PHASE B FUSE HOLDER SUGGEST THE FUSE TURNED INTO A 436W HEATER ELEMENT AT THE TIME OF FAILURE. THIS WOULD PROVIDE ENOUGH ENERGY TO CREATE THE DAMAGE SEEN. A CURRENT LIMITING / TIMING DELAY FUSE HAS A HIGHER HEAT CAPACITY THAT A FAST ACTING FUSE. (B)(4) BELIEVES THAT THE COMBINATION OF THREE FACTORS (POWER BROWN OUTS, PULSING LOAD AND THERMAL ISOLATION) ALLOWED THE FUSE IN QUESTION TO BE REPEATEDLY HEATED AND COOLED. THIS TEMPERATURE CYCLING CAUSED THE FUSE TO PARTIALLY MELT INTERNALLY, CREATING A 180 OHM BRIDGE MEASURED. THIS BRIDGING TURNED THE FUSE INTO A HEATER. WITH NO WAY TO...

    Additional Manufacturer Narrative · 1

    MAR COR WAS NOTIFIED OF A FIRE WITHIN THE HX2 CONTROL PANEL ON (B)(6) 2015. MANUFACTURER OF THE ELECTRICAL PANEL'S PRELIMINARY INVESTIGATION SHOW A FUSE IN THE FUSE BLOCK FAILED TO COMPLETELY OPEN. THE ROOT CAUSE IS CURRENTLY UNDER INVESTIGATION. THIS FAILURE OCCURRED WITHIN A FULLY ENCLOSED ELECTRICAL PANEL. THE PANEL AND RO SYSTEM MEET SAFETY REQUIREMENTS AND HAVE BEEN TESTED PER ANSI/UL 61010-1. THIS FAILURE PRESENTS NO RISK TO PATIENTS OR THE USER. MAR COR WILL CONTINUE TO MONITOR THIS COMPLAINT WITHIN THE COMPLAINT SYSTEM.

    Description of Event or Problem · 1

    .

    Description of Event or Problem · 1

    BIOPURE HX2 RO SYSTEM CONTROL HAD A FIRE INSIDE THE ELECTRICAL CABINET. THIS HAPPENED OVER A WEEKEND WITH NO PATIENTS OR OPERATORS AFFECTED. HX2 WAS EVALUATED AND REPAIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729007 BIOPURE HX2 REVERSE OSMOSIS WATER TREATMENT SYSTEM, PRODUCT CODE: FIP FIP MAR COR PURIFICATION 3029712

    Patients

    Seq Age Sex Outcome Treatment
    1