BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED SAFESET TRANSPAC SETS

    MDR report key: 21054404 · Received January 2, 2025

    Report

    Report Number
    9617594-2025-00003
    Event Type
    Malfunction
    Date Received
    January 2, 2025
    Date of Event
    December 1, 2024
    Report Date
    May 5, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    DRS
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED COMPLAINT COULD NOT BE CONFIRMED. NO PRODUCT SAMPLES, PICTURES, OR VIDEOS WERE RECEIVED FOR INVESTIGATION. THEREFORE, A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED AND A CAUSE CANNOT BE DETERMINED. A MANUFACTURING RECORD REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. LOT HISTORY REVIEW COULD NOT BE CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED.

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE WILL BE RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. A DEVICE HISTORY REVIEW COULD NOT BE COMPLETED DUE TO THE UNKNOWN LOT NUMBER. D4: NO PRODUCT INFORMATION IS AVAILABLE; THEREFORE, UDI INFORMATION IS UNKNOWN. G4: POSSIBLE 510K #S: K932188, K061573, K932141, K052828. DISTRIBUTOR CONTACT INFORMATION: (B)(4).

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED AN UNSPECIFIED SAFESET TRANSPAC SETS. THE DISTRIBUTOR REPORTED THE EVENT AND STATED THAT THEY WERE ASKING FOR HELP REGARDING MRI LINES BECAUSE THEIR CUSTOMER HAS BEEN HAVING ISSUES WITH SAFESET TRANSPAC SETS. THE CUSTOMER CLAIMS THAT THEY HAVE BEEN HAVING ISSUES OF UNDERDAMPING IN ARTERIAL PRESSURE MEASUREMENT, ESPECIALLY IF USING SAFESET LINE. THEY CHECKED AND THERE IS NO ISSUE WITH MONITOR OR PATIENT CANNULA. THERE IS UNKNOWN PATIENT INVOLVEMENT; HARM WAS NOT REPORTED AS A CONSEQUENCE OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1375559 UNSPECIFIED SAFESET TRANSPAC SETS UNK DRS ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown