BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18771758 · Received February 23, 2024

    Report

    Report Number
    9610825-2024-00099
    Event Type
    Malfunction
    Date Received
    February 23, 2024
    Date of Event
    January 23, 2024
    Report Date
    June 7, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). EVENT 1 NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: RECEIVED 4 SAMPLES WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BBC OF COMPLAINT SAMPLE WERE 22N12GEA81. ALL SAMPLES WERE FILLED WITH SOLUTION AND BBC WERE REMOVED. ALL SAMPLES WERE DETECTED LEAKAGE AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. AN APPROVED PROJECT HAD BEEN RAISED TO ADDRESS TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION LEAKAGE ISSUE. SUMMARY OF ROOT CAUSE ANALYSIS: THE COMPLAINT SAMPLES WERE LEAKING AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. THUS, WE CONSIDERED THIS COMPLAINT AS CONFIRMED. CAUSE : FAILURE IN PRODUCTION PROCESS CORRECTIONS/CONTAINMENT PLANS WITH EFFECTIVE DATE: NOTA APPLICABLE JUSTIFICATION: CONFIRMED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). EVENT 1 A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 0

    EVENT 1 AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN TURKEY: "CHEMO LEAKAGE" ACCORDING TO THE CUSTOMER: THE PHARMACIST OF THE HOSPITAL CLAIMS THAT LEAKAGE OCCURRED ON 4 PUMPS. ONE PUMP WAS LEAKING AFTER IT HAD BEEN ATTACHED TO THE PATIENT. NO ADVERS EVENT WAS REPORTED REGARDING THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237402 EASYPUMP 2 ELASTOMERIC PUMPS MEB B BRAUN MELSUNGEN AG 4540016-20 22N12GEA81

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown