BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HLS SET

    MDR report key: 24673498 · Received March 24, 2026

    Report

    Report Number
    8010762-2026-0000139
    Event Type
    Malfunction
    Date Received
    March 24, 2026
    Date of Event
    March 19, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE INVESTIGATION IS ONGOING. FURTHER INFORMATION HAS BEEN REQUESTED BUT HAS NOT YET BEEN RECEIVED. A FOLLOW UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE DUTCH 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 THE NETHERLANDS. IT WAS REPORTED THAT DURING PRIMING THE HLS SET, A PROBLEM WITH THE PART PRESSURE, WHICH DID NOT MEASURE, WAS DETECTED. FURTHER INSPECTION OF THE HLS SET INDICATED A SMALL TEAR IN THE DATA CONNECTION CABLE ON THE HLS MODULE. NO PATIENT WAS INVOLVED. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION WILL BE SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736575 HLS SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH BE-HLS 7050 #SHLS SET ADVANCED 7.0 3000517356 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown