BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 21963077 · Received May 5, 2025

    Report

    Report Number
    9610825-2025-00268
    Event Type
    Malfunction
    Date Received
    May 5, 2025
    Date of Event
    January 14, 2025
    Report Date
    September 19, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4), PREMARKET SUBMISSION # K092313, K172831, K191910.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION #. K092313. K172831. K191910. THE UPLOADED HISTORY FILES COULD NOT BE ANALYZED, AS THE DATA FROM THE INCIDENT DATE (B)(6) 2025 - IS NO LONGER AVAILABLE. THE PUMP WAS INSPECTED LOCALLY IN MEXICO, AND NO TECHNICAL MALFUNCTION WAS IDENTIFIED. THEREFORE, THE DEFECT COULD NOT BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: "IT WAS REPORTED THAT AT 3:00 P.M. THE INFUSIONS WERE REVIEWED, AND IT WAS NOTICED THAT IN 24 HOURS ONLY 4 ML OF A 1 MG MORPHINE PREPARATION TITRATED TO 0.9% SS 24 ML WAS INFUSED, WHICH BEGAN AT 5:00 P.M. ON (B)(6) 2025, AND AS OF TODAY, (B)(6) 2025, ONLY 4 ML HAS BEEN INFUSED." ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422853 PERFUSOR® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713030

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown