BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HL-20 INTEGRATED PERFUSION SYSTEM

    MDR report key: 4283360 · Received November 28, 2014

    Report

    Report Number
    8010762-2014-00559
    Event Type
    Injury
    Date Received
    November 28, 2014
    Date of Event
    June 10, 2011
    Report Date
    December 28, 2011
    Manufacturer
    MAQUET CARDIOPULMONARY AG
    Product Code
    DTQ
    PMA / PMN Number
    K943803
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEVICE WAS INSPECTED BY A MAQUET SAS FIELD SERVICE TECHNICIAN (FST). THE FST COULD NOT REPRODUCE THE DEVICE PROBLEM. THE DEVICE WAS TESTED ACCORDING TO THE SPECIFICATIONS AND WAS FUNCTIONING WITHOUT ANY PROBLEMS. THERE IS NO "ERREUR SYS" IN THE HL20 MANUAL. SINCE THE PROBLEM COULD NOT BE REPRODUCED NO REPAIR OR OTHER CORRECTIONS WERE PERFORMED ON THE UNIT. REFERENCE: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, (B)(6), RECEIVED A REPORT FROM THE (B)(6) ABOUT AN EVENT THAT OCCURRED ON (B)(6)2011 INVOLVING A HL20 ROLLER PUMP MODULE RPM 20-320 SINGLE ROLLER PUMP (ARTICLE NUMBER: 70102.7652, SERIAL NUMBER: (B)(4)). WHILE USING THE HL20, AFTER ABOUT 40 MINUTES OF STARTING AN ECC PROCEDURE THE ARTERIAL PUMP STOPPED AND AN "ERREUR SYS" ERROR MESSAGE WAS DISPLAYED. SEVERAL ATTEMPTS WERE MADE TO RESTART THE PUMP WITHOUT SUCCESS, WITH THE ERROR MESSAGE "ERR EEPROM" BEING DISPLAYED. A PERFUSIONIST RETRIEVED A PUMP FROM A BACKUP CONSOLE, AND DURING THIS TIME THE ECC PROCEDURE CONTINUED USING MANUAL HAND CRANKING OF THE PUMP. THE REPLACEMENT PUMP WAS THEN ATTACHED TO THE UNIT. REFERENCE: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    771548 HL-20 INTEGRATED PERFUSION SYSTEM CONSOLE, HEART/LUNG MACHINE DTQ MAQUET CARDIOPULMONARY AG MCP00703309

    Patients

    Seq Age Sex Outcome Treatment
    1