BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARESITE®

    MDR report key: 19488697 · Received June 7, 2024

    Report

    Report Number
    2523676-2024-00599
    Event Type
    Malfunction
    Date Received
    June 7, 2024
    Date of Event
    May 18, 2024
    Report Date
    November 27, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K140311
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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 INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. THE ACTUAL DEFECTIVE DEVICE IS A VALUABLE TOOL IN INVESTIGATING THE CAUSE OF THIS INCIDENT. 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

    AS REPORTED BY THE USER FACILITY: ON (B)(6) 2024, WHILE IN INTENSIVE CARE, DURING DISCONNECTION OF THE DORAN AHP12 EXTENSION CONNECTED TO THE BIDIRECTIONAL VALVE, THE MALE LUER OF THE AHP12 BROKE OFF IN THE FEMALE LUER OF THE VALVE. AN AIR BUBBLE WAS VISUALIZED IN ONE OF THE KTC LINES AT THE TIME OF BREAKAGE. THE LINE WAS CLAMPED IMMEDIATELY. PROVEN CONSEQUENCES: THE PATIENT SHOWED NO CLINICAL SIGNS IN THE AFTERMATH, AND VITAL PARAMETERS WERE NOT AFFECTED. RESIDENT ON CALL NOTIFIED: ALL CLEAR. LINE CHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1310738 CARESITE® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061904492

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown