BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SET

    MDR report key: 25146972 · Received May 12, 2026

    Report

    Report Number
    8010762-2026-0000222
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 11, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DTZ
    UDI-DI
    04058863005744
    PMA / PMN Number
    K112360
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. NOTE: THIS EVENT OCCURRED ON THE AUSTRALIAN 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 AUSTRALIA DURING PRIMING PROCEDURE ON (B)(6) 2026 IT WAS REPORTED THAT THE INTERNAL PRESSURE FOR PART WASN'T READING. TO INVESTIGATE, THE CUSTOMER PERFORMED A REBOOT OF THE CIRCUIT WITHOUT SUCCESS. THE SENSOR CONNECTOR WAS CHECKED AND WAS FOUND TO BE ATTACHED CORRECTLY. THE INTERNAL COMPONENTS WEREN'T BENT OR CLOGGED. FURTHER THE SENSOR CONNECTOR WAS SWAPPED WITH A DIFFERENT PROBE TO CHECK IF THE ISSUE WAS ISOLATED TO THE PRESSURE MONITORING CABLE, HOWEVER, THE PRESSURE WAS STILL NOT READING. A PRACTICE CIRCUIT WAS CONNECTED TO THE INVOLVED CARDIOHELP DEVICE AND THE PRESSURES COULD BE READ. THE INVOLVED CARDIOHELP DEVICE COULD BE EXCLUDED AS THE FAULT. NO VISIBLE DEFECT WAS NOTED ON THE HLS SET. IT WAS CONFIRMED THAT THE PRESSURES WERE ZEROED FREE OF LIQUID. FURTHER, NO ENVIRONMENTAL CONDITIONS WHICH COULD HAVE INFLUENCED THE EVENT WERE PRESENT AT TIME OF PRIMING. NO HARM TO ANY PERSON HAS BEEN REPORTED. AS A PRESSURE READING ISSUE CAN LEAD TO A PUMP STOP, IF THE INTERVENTION IS SET BY THE USER, A REPORT IS REQUIRED. COMPLAINT ID # (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280662 TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS DTZ MAQUET CARDIOPULMONARY GMBH 3000521200 04058863005744

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown