BEUDAMED
    FDA Adverse Event Death Summary report: N

    HLS SET

    MDR report key: 21970048 · Received May 6, 2025

    Report

    Report Number
    3013876692-2025-00037
    Event Type
    Death
    Date Received
    May 6, 2025
    Date of Event
    November 16, 2024
    Report Date
    May 6, 2025
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICE ON 2025-04-01: "THE VIGILANCE UNIT OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT, INVOLVING ¿PLS SET¿, UDI-DI (B)(4) MANUFACTURED BY GETINGE WHICH OCCURRED ON 2024-11-16, IN HOSPITAL (B)(6). THE FOLLOWING INFORMATION WAS PROVIDED: INCIDENT DESCRIPTION: DEATH." BASED ON THE INFORMATION AVAILABLE THAT THE PATIENT EXPIRED, A REPORT IS REQUIRED. HOWEVER, THE SSU CONFIRMED ON 2025-04-20, THAT THE AFFECTED PRODUCT IN QUESTION WAS AN HLS SET NOT A PLS SET. AFTER CONSULTATION WITH THE CUSTOMER, THE SSU CONFIRMED ON 2025-04-24, THAT THE INVOLVED HLS SET WAS FUNCTIONING AS INTENDED AND HAD NO MALFUNCTION. THE PATIENT PASSED AWAY DUE TO HIS DISORDERS. THE AFFECTED HLS SET WAS DISCARDED BY THE CUSTOMER. BASED ON THE AVAILABLE INFORMATION THE REPORTED EVENT "DEATH" COULD BE CONFIRMED BUT WAS NOT RELATED TO A DEVICE MALFUNCTION. THIS COMPLAINT WAS FOUND IN THE DATABASE OF CUSTOMER COMPLAINTS AS A SINGLE EVENT (TIMEFRAME FROM 2024-03-31 TILL 2025-03-31). THE CUSTOMER WILL BE INFORMED ABOUT THE RESULTS BY THE GETINGE SALES AND SERVICE UNIT. THE OCCURRENCE RATE RELATED TO THE REPORTED ISSUE IS CURRENTLY BEING MONITORED AS PART OF MAQUET CARDIOPULMONARY¿ S TRENDING PROGRAM AND ADDITIONAL INVESTIGATIONS OR CORRECTIONS WILL BE IMPLEMENTED IN CASE OF ADVERSE TRENDING. NOTE: THIS EVENT OCCURRED ON THE SPANISH MARKET. IT IS A SIGNIFICANTLY SIMILAR DEVICE TO "HLS SET¿ WHICH IS SOLD IN THE USA UNDER PREMARKET SUBMISSION NUMBER K112360. FOR SECTION D4 ALL AVAILABLE IDENTIFYING INFORMATION IS FOR THE OUT OF THE US DEVICE, SUBJECTED TO THIS REPORT. THEREFORE, NO GUDID INFORMATION EXISTS. FURTHERMORE, UDI INFORMATION (PRIMARY DI NUMBER) PROVIDED IN D4 IS FOR HLS SET WITH CATALOG NUMBER: 701069073.

    Description of Event or Problem · 0

    THE EVENT OCCURRED IN SPAIN. MAQUET CARDIOPULMONARY GMBH HAS RECEIVED THE FOLLOWING INFORMATION FROM THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICE ON 2025-04-01: THE VIGILANCE UNIT OF MEDICAL DEVICES OF THE SPANISH AGENCY OF MEDICINES AND MEDICAL DEVICES HAS BEEN INFORMED THROUGH RENACER REGISTRY ABOUT AN INCIDENT, INVOLVING ¿PLS SET¿, UDI-DI (B)(4) MANUFACTURED BY GETINGE WHICH OCCURRED ON 2024-11-16, IN HOSPITAL (B)(6). THE FOLLOWING INFORMATION WAS PROVIDED: INCIDENT DESCRIPTION: DEATH." THE GETINGE SALES AND SERVICE UNIT (SSU) CONFIRMED ON 2025-04-20, THAT THE AFFECTED PRODUCT IN QUESTION WAS AN HLS SET NOT A PLS SET. BASED ON THE INFORMATION AVAILABLE THAT THE PATIENT EXPIRED, A REPORT IS REQUIRED. COMPLAINT ID#: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84490 HLS SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH HLS SET 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death UNKNOWN.