BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOTHERM 400CE

    MDR report key: 6361413 · Received February 27, 2017

    Report

    Report Number
    1516825-2017-00003
    Event Type
    Malfunction
    Date Received
    February 27, 2017
    Date of Event
    November 7, 2016
    Report Date
    February 27, 2017
    Manufacturer
    CINCINNATI SUB-ZERO, LLC.
    Product Code
    DWC
    PMA / PMN Number
    K122813
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CINCINNATI SUB-ZERO RECEIVED A COMPLAINT STATING A FUSE BLEW DURING A PROCEDURE CAUSING THE DEVICE TO MALFUNCTION. THE TECHNICIAN FOUND THE PUMP MALFUNCTIONING DUE TO A BLOWN FUSE. PER THE CSZ SERVICE MANUAL, THE HEMOTHERM MUST BE SERVICED AND/OR PREVENTIVE MAINTENANCE MUST BE PERFORMED AT SPECIFIC INTERVALS AS OUTLINED IN THE MANUAL. IMPROPER REPAIR AND INADEQUATE MAINTENANCE CAN RESULT IN DAMAGE TO THE HEMOTHERM SYSTEM AND PATIENT INJURY. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR DEVICES. CSZ HAS RECEIVED DEVICE AND SHIPPED A REPLACEMENT TO THE ACCOUNT. THE TECHNICIAN REPLACED THE FUSE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    CINCINNATI SUB-ZERO RECEIVED A REPORT FROM THE ACCOUNT STATING THE FUSE BLEW ON THE DEVICE DURING A PROCEDURE. THE DEVICE WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142482 HEMOTHERM 400CE CARDIOPULMONARY BYPASS TEMPERATURE CONTROLLER. DWC CINCINNATI SUB-ZERO, LLC. 86022

    Patients

    Seq Age Sex Outcome Treatment
    1