BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSOMAT®

    MDR report key: 21825509 · Received April 11, 2025

    Report

    Report Number
    9610825-2025-00245
    Event Type
    Injury
    Date Received
    April 11, 2025
    Date of Event
    March 8, 2025
    Report Date
    April 11, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    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 # K083689. K142596. THREE BATCHES WERE REPORTED FOR THIS COMPLAINT, BUT NO BATCH CAN BE PRECISELY ASSIGNED TO THIS COMPLAINT: 24N21E8ST5; 22D16E8ST2; 22B03E8ST1. TO NOTE: THE COMBINATION OF THE THREE BATCH NUMBERS 24N21E8ST5; 22D16E8ST2; 22B03E8ST1 AND THE ARTICLE NUMBER (B)(4) REGISTERED IN THE CC-NOTIFICATION DOES EXIST IN THE SAP SYSTEM. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED CUSTOMER PICTURES WERE TAKEN TO A VISUAL INSPECTION ACCORDING TEST METHOD 102002 DAMAGES. TWO CUSTOMER PICTURES SHOW AN INFUSOMAT PUMP WITH AN INSERTED INFUSOMAT TUBE. IT IS VISIBLE THAT BLOOD HAS LEAKED FROM UNDERNEATH THE INFUSOMAT PUMP. HOWEVER, IT IS NOT CLEAR WHAT CAUSED THIS LEAK. IT IS NOT POSSIBLE TO CHECK THE GREEN LOCKING CLAMP TO SEE IF THE CLAMPING SLIT HAS SHARP EDGES BASED ONLY WITH THE CUSTOMER PICTURES. THE THIRD CUSTOMER IMAGE SHOWS THAT THE BLOOD HAS LEAKED TO THE FLOOR. FUNCTIONAL INSPECTION: A FUNCTIONAL TEST CANNOT BE CARRIED OUT BECAUSE NO SAMPLE WAS RECEIVED. SUMMARY AND ASSESSMENT: BASED ON THE CONDUCTED INVESTIGATIONS NO PROPER EVALUATION IS POSSIBLE ON THE BASIS ONLY OF THE PICTURES. THEREFORE, THE DEFECT IS CONSIDERED AS NOT CONFIRMED. HOWEVER, IF THE COMPLAINT SAMPLE WILL BE PROVIDED, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER: AFTER 15 MINUTES OF DIALYSIS SESSION. THE PATIENT CALLS OUT BECAUSE SHE'S NOT FEELING WELL, A VERY LARGE VENOUS RETURN IS OBSERVED IN THE TUBING UP TO THE PUMP, A LEAK IN THE SYRINGE PUMP TUBING AT THE GREEN CLAMP. A LARGE QUANTITY OF BLOOD HAS FLOWED OUT, AROUND 1500 ML ESTIMATED BY THE DOCTOR." PATIENT CONSEQUENCES: ARTERIAL HYPOTENSION. HYPOVOLEMIC SHOCK. LOSS OF HEMOGLOBIN. LOSS OF CONSCIOUSNESS WITH VITAL RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2424808 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8700036SP

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening