BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEMOCONCENTRATOR

    MDR report key: 8910015 · Received August 20, 2019

    Report

    Report Number
    8010762-2019-00252
    Event Type
    Malfunction
    Date Received
    August 20, 2019
    Date of Event
    June 14, 2019
    Report Date
    November 19, 2019
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    KDI
    PMA / PMN Number
    K123288
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY HAS RECEIVED A SIMILAR COMPLAINT FROM THIS FAILURE.THE INVESTIGATON HAS BEN PERFORMED BASED ON THE COMPLAINT #231439. ACCORDING TO THE SAMPLE INVESTIGATION OF THE COMPLAINT #(B)(4); MAQUET CARDIOPULMONARY REQUESTED THE PRODUCT BACK FOR MANUFACTURER INVESTIGATION.THE FAILURE COULD BE CONFIRMED BASED ON THE LABORATORY INVESTIGATION. (B)(4). DEVICE HISTORY RECORD WAS REVIEWED. THERE WERE NO REFERENCES FOUND WHICH ARE INDICATING A NONCONFORMANCE OF THE PRODUCT IN QUESTION. GETINGE CARDIOPULMONARY ANTALYA HAS BEEN INITIATED SCAR (SUPPLIER CORRECTIVE ACTION REQUEST) 751001239.SCAR HAS BEEN CLOSED SINCE SUPPLIER EVALUATED THE ISSUE AND CONFIRMED THE FAILURE.CAUSE OF THE FAILURE ACCORDING TO THE SUPPLIER IS SLIP DURING VISUAL INSPECTION.AS A CORRECTIVE ACTION, INFORMATION ABOUT THE COMPLAINT GOES TO THE RESPONSIBLE DEPARTMENT.FURTHER ACTIONS WILL BE TAKEN IN PROCESSOF CONTINUOUS IMPROVEMENT. THIS COMPLAINT IS BEING MONITORED AS PART OF THE COMPLAINT DATA TRENDING OF MAQUET CARDIOPULMONARY GMBH AND FURTHER INVESTIGATIONS AND MEASURES WILL BE CONDUCTED IN CASE OF ADVERSE TRENDING.

    Description of Event or Problem · 0

    COMPLAINT: #(B)(4).

    Description of Event or Problem · 1

    DURING THE CPB (CARDIOPULMONARY BYPASS) BLOOD LEAKED TO THE WASTE LINE. IT WAS NOT HEMOLYSIS, BUT WAS JUDGED TO BE BLOOD LEAKAGE AND WAS DISCONTINUED. COMPLAINT NO: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705779 HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI MAQUET CARDIOPULMONARY GMBH BC140PLUS 92228535

    Patients

    Seq Age Sex Outcome Treatment
    1