BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HL20

    MDR report key: 3697954 · Received January 8, 2014

    Report

    Report Number
    8010762-2014-00004
    Event Type
    Malfunction
    Date Received
    January 8, 2014
    Date of Event
    December 8, 2013
    Report Date
    December 9, 2013
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS UNCLEAR AT THIS TIME WHETHER THE CUSTOMERS CONCERN IS THE RESULT OF A DEVICE MALFUNCTION. A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CUSTOMER SUSPECTED AN ISSUE WITH THE INTERNAL CIRCUIT BOARD OF AN HL20 TWO POSITION PUMP FOR ECLS. THEY BELIEVED EITHER THE HL20 PUMP BASE OR SINGLE ROLLER PUMP COULD BE THE ISSUE. THE PUMP SOFT ALARMS WERE SET IN THE OFF POSITION. PRESSURE CHANNEL 3 WAS SLOWING DOWN ARTERIAL ROLLER PUMP WHEN PRESSURE REACHED NEGATIVE LL OF -15MMHG. THE SETTING WAS AT -25MMHG WHICH MEANS IT WAS WORKING PROPERLY. NO ALARMS WERE GOING OFF DUE TO SOFT ALARMS BEING OFF. MAQUET PERFUSION TERRITORY MANAGER SPOKE WITH ECLS COORDINATOR AND SUGGESTED THEY ADJUST THE ALARM SETTING OR TREAT THE PT TO RESOLVE THE ALARM. THE CUSTOMER ADJUSTED THE ALARM SETTING. NO REPORTED PT EFFECTS. REF: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    14555 HL20 HL20 TWO POSITION PUMP DTQ MAQUET CARDIOPULMONARY AG 100181 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NI