BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TUBING SETS

    MDR report key: 24312552 · Received February 11, 2026

    Report

    Report Number
    8010762-2026-0000058
    Event Type
    Malfunction
    Date Received
    February 11, 2026
    Report Date
    April 28, 2026
    Manufacturer
    MAQUET CARDIOPULMONARY GMBH
    Product Code
    DWE
    UDI-DI
    04037691002880
    PMA / PMN Number
    K053025
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS CONFIRMED BY SALES & SERVICE REPRESENTATIVE THAT THIS COMPLAINT IS A DUPLICATE COMPLAINT OF ONETRACK #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000001) AND OPENED BY A MISUNDERSTANDING. THEREFORE, THIS COMPLAINT #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000058) WILL BE CANCELLED AND ALL FURTHER INVESTIGATION WILL BE PERFORMED AND RESULTS WILL BE SHARED WITHIN THE ORIGINAL COMPLAINT RECORD ONETRACK #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000001). COMPLAINT #(B)(4).

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    A FOLLOW-UP MEDWATCH WILL BE SUBMITTED WHEN FURTHER INFORMATION BECOMES AVAILABLE. IT WAS INITIALLY REPORTED THAT THIS COMPLAINT WAS A DUPLICATE OF COMPLAINT ID #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000001). HOWEVER, ON 2026-03-06, THE SALES & SERVICE REPRESENTATIVE CONFIRMED WITH THE CUSTOMER THAT THIS COMPLAINT IS NOT A DUPLICATE. THEREFORE, COMPLAINT #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000058) REMAINS VALID AND WILL BE HANDLED AS AN INDEPENDENT COMPLAINT RECORD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE BARRIER (TYVEK) OF CUSTOM TUBING PACK WAS FOUND AS OPENED. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE IS RELATED WITH STERILE BARRIER FAILURE, THE COMPLAINT IS REPORTABLE. IT WAS CONFIRMED BY SALES & SERVICE REPRESENTATIVE THAT THIS COMPLAINT IS A DUPLICATE COMPLAINT OF ONETRACK #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000001) AND OPENED BY A MISUNDERSTANDING. THEREFORE, THIS COMPLAINT #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000058) WILL BE CANCELLED AND ALL FURTHER INVESTIGATION WILL BE PERFORMED AND RESULTS WILL BE SHARED WITHIN THE ORIGINAL COMPLAINT RECORD ONETRACK #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000001).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE BARRIER (TYVEK) OF CUSTOM TUBING PACK WAS FOUND AS OPENED. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE IS RELATED WITH STERILE BARRIER FAILURE, THE COMPLAINT IS REPORTABLE. COMPLAINT # (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STERILE BARRIER (TYVEK) OF CUSTOM TUBING PACK WAS FOUND AS OPENED. NO HARM TO ANY PERSON WAS REPORTED. SINCE THE FAILURE IS RELATED WITH STERILE BARRIER FAILURE, THE COMPLAINT IS REPORTABLE. COMPLAINT #(B)(4). IT WAS INITIALLY REPORTED THAT THIS COMPLAINT WAS A DUPLICATE OF COMPLAINT ID #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000001). HOWEVER, ON 2026-03-06, THE SALES & SERVICE REPRESENTATIVE CONFIRMED WITH THE CUSTOMER THAT THIS COMPLAINT IS NOT A DUPLICATE. THEREFORE, COMPLAINT #(B)(4) (MFG REPORT NUMBER: 8010762-2026-0000058) REMAINS VALID AND WILL BE HANDLED AS AN INDEPENDENT COMPLAINT RECORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    312228 TUBING SETS TUBING, PUMP, CARDIOPULMONARY BYPASS DWE MAQUET CARDIOPULMONARY GMBH HQV 51201 3000455144 04037691002880

    Patients

    Seq Age Sex Outcome Treatment
    1