BEUDAMED
    FDA Adverse Event Injury Summary report: N

    XP4:1B MYOTHERM XP

    MDR report key: 22911986 · Received August 28, 2025

    Report

    Report Number
    2184009-2025-01031
    Event Type
    Injury
    Date Received
    August 28, 2025
    Date of Event
    August 12, 2025
    Report Date
    October 10, 2025
    Manufacturer
    PERFUSION SYSTEMS
    Product Code
    DTN
    PMA / PMN Number
    K162958
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AN INITIAL REGULATORY REPORT WAS ALREADY REPORTED VIA REGULATORY REPORT NUMBER 6000033-2025-00110 IN PE (B)(4). SUPPLEMENTAL REGULATORY REPORT SUBMITTED VIA 6000033-2025-00110 BASED ON ADDITIONAL INFORMATION RECEIVED CONFIRMING OCCURRENCES OCCURRED ON DIFFERENT DATES. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT MEDTRONIC TUBING WAS NOT USED IN THIS CASE. CLAMPS OR LOCKING CONNECTORS WERE NOT USED AT THE TIME THE EVENT OCCURRED. THE CUSTOMER RECEIVED THEIR TUBING FROM A SEPARATE SUPPLIER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION THAT DURING USE OF THE MYOTHERM HEAT EXCHANGER, IT WAS REPORTED THAT THERE WAS AN ISSUE WITH CARDIOPLEGIA TUBING POPPING OFF THE MYOTHERM OUTLET ON THIS OCCASION, LEADING TO THE PERFUSIONISTS BEING SPLASHED AND NEEDING BLOOD TESTS FOR POTENTIAL INFECTION. CUSTOMER CLEANED AND FLUSHED THE DEVICE. USE OF DEVICE WAS UNSPECIFIED. THERE WAS NO ADVERSE PATIENT EFFECT ASSOCIATED WITH THIS EVENT. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE CUSTOMER WAS AT A HIGH RISK FOR INFECTION. TWO LOT NUMBERS OF MYOTHERM WERE INCLUDED IN THE CUSTOM PACK: 230710237 AND 230710238.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2520787 XP4:1B MYOTHERM XP RESERVOIR, BLOOD, CARDIOPULMONARY BYPASS DTN PERFUSION SYSTEMS 61399405331

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention