BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUCTION AND ANTICOAGULANT LINE

    MDR report key: 20864792 · Received December 6, 2024

    Report

    Report Number
    9612164-2024-05840
    Event Type
    Malfunction
    Date Received
    December 6, 2024
    Date of Event
    November 25, 2024
    Report Date
    January 7, 2025
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    DWD
    UDI-DI
    00613994744975
    PMA / PMN Number
    K812292
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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

    ADDITIONAL INFORMATION B5: MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S BLOOD WAS DISCARDED BECAUSE OF THE ISSUE. IT WAS ESTIMATED THAT APPROXIMATELY 300 TO 400 ML OF WHOLE BLOOD WAS DISCARDED. ADDITIONAL REVIEW OF THE EVENT SHOWS THE PATIENT RECEIVED A TRANSFUSION OF AUTOLOGOUS BLOOD. A TRANSFUSION OF AUTOLOGOUS BLOOD WOULD HAVE BEEN AN EXPECTED PART OF THE PROCEDURE AS THE FUNCTION OF THE AUTOLOG AUTOTRANSFUSION SYSTEM IS TO PROVIDE AUTOLOGOUS BLOOD DURING SURGICAL PROCEDURES. THERE IS NO INFORMATION TO REASONABLY SUGGEST THAT THE DEVICE IN THIS REPORT MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. THE TYPE OF REPORTABLE EVENT HAS BEEN UPDATED TO A MALFUNCTION IN H1. CORRECTION SECTION D: THE MANUFACTURER'S NAME AND POSTAL CODE HAVE BEEN UPDATED. 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 AN EL RESERVOIR, AUTOLOG WASH KIT AND SUCTION AND ANTICOAGULANT ASSEMBLY, IT WAS REPORTED THAT THE PRODUCT SUDDENLY FRACTURED AT THE CONNECTION POINT OF THE TUBING TO THE IV FLUID DRIP, CAUSING FLUID TO SPILL ONTO THE FLOOR AND THE TUBING TO FALL, BECOMING CONTAMINATED. THE CUSTOMER IMMEDIATELY PICKED IT UP AND HANDLED THE SITUATION. THE CUSTOMER ASSESSED THAT THE COLLECTED BLOOD HAD BEEN EXPOSED TO CONTAMINATION, RAISING CONCERNS ABOUT INFECTION, AND DETERMINED THAT THE ENTIRE SET NEEDED TO BE REPLACED. TO ENSURE THE PATIENT'S TRANSFUSION SAFETY, A NEW SET OF AUTOLOGOUS BLOOD RECOVERY SUPPLIES WAS REPLACED. BLOOD COLLECTION AND WASHING WERE RESTARTED. AFTER THE SURGERY, THE PATIENT EXPERIENCED NO ADVERSE REACTIONS FROM THE AUTOLOGOUS BLOOD TRANSFUSION. SEE ATTACHED PHOTO. MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE PATIENT'S OWN BLOOD WAS TRANSFUSED. THERE WAS NO ISSUE WITH THE EL RESERVOIR OR WITH THE AUTOLOG WASH KIT. DUE TO THE SURGEON'S FOCUS ON THE OPERATION, THE EXTRACORPOREAL CIRCULATION TECHNICIAN INFORMED THE SURGEON POST-SURGERY. SINCE, NO ABNORMAL EVENTS OCCURRED, THE SURGEON DID NOT INVESTIGATE THE CAUSE FURTHER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2119716 SUCTION AND ANTICOAGULANT LINE SUCTION CONTROL, INTRACARDIAC, CARDIOPULMONARY DWD MEDTRONIC MEXICO S. DE R.L. DE CV BT725 228215390 00613994744975

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female