BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR®

    MDR report key: 20277782 · Received September 23, 2024

    Report

    Report Number
    9610825-2024-00719
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 15, 2024
    Report Date
    November 19, 2024
    Manufacturer
    B. BRAUN AVITUM AG
    Product Code
    FRN
    UDI-DI
    04046964797958
    PMA / PMN Number
    K172831
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS STILL ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT NUMBER (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. FURTHER INVESTIGATION OF THE COMPLAINT IS NOT POSSIBLE WITHOUT A DEVICE. IF THE DEVICE DOES BECOME AVAILABLE, THE COMPLAINT WILL BE REOPENED FOR FURTHER EVALUATION. ALL INFORMATION CONCERNING THIS REPORTED INCIDENT HAS BEEN INCLUDED IN OUR TREND ANALYSIS OF THE PRODUCT LINE.

    Description of Event or Problem · 0

    AS REPORTED BY USER FACILITY: NURSE SHOWER THERE WAS A HALF GIVEN OFIRMEV SYRINGE DOSE. THE DOSE WAS PROGRAMMED TO 198 MG=19.8 MLS. HOWEVER, THERE IS 8 MLS OF MEDICATION LEFT IN THE SYRINGE. MEDICATION WAS SCANNED AT 16:44 AND THE NIGHT NURSE NOTICED THE SYRINGE WHEN SHE WAS GOING TO HANG HER NEXT SYRINGE MEDICATION AT 21:45. OTHER NURSE WERE PRESENT TO CONFIRN THAT 8ML WERE LEFT IN THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1502252 PERFUSOR® PUMP, INFUSION FRN B. BRAUN AVITUM AG 97040039J2 04046964797958

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown