BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18711385 · Received February 15, 2024

    Report

    Report Number
    9610825-2024-00086
    Event Type
    Malfunction
    Date Received
    February 15, 2024
    Report Date
    April 24, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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. 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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. UPDATED INFORMATION D9 - DEVICE RETURNED TO MANUFACTURER DATE H5 - DEVICE MANUFACTURER DATE H6 - CODES UPDATED. ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: RECEIVED 1 COMPLAINT SAMPLES WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BBC OF COMPLAINT SAMPLE WAS (B)(4). THE SAMPLE WAS FILLED WITH SOLUTION AND BBC WERE REMOVED. THE SAMPLE WAS DETECTED LEAKAGE AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. ANALYSIS: THIS COMPLAINT BATCH WAS A REWORK BATCH WITH HOLDBACK AT FINAL CONTROL INSPECTION ON LEAKING AT FILLING PORT & LEAKING AT BBC. THE HOLDBACK BATCH WAS REWORKED ACCORDING TO SOP HC-MY01-M-5-4-16-021. AFTER THE BATCH WAS REWORKED, IT WAS TESTED ACCORDING TO SPECIFICATION (HC-MY01-M-5-4-10-601-0) AND RELEASED AFTER THE PRODUCTS ARE TESTED TO BE WITHIN SPECIFICATION. AN APPROVED PROJECT HAS BEEN INITIATED TO ADDRESS STEP DOWN TUBE - TRIANGLE TUBE LEAKAGE ISSUE. UPON THE ROOT CAUSES WERE IDENTIFIED, MITIGATION ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THE ISSUE. THE MAJOR CONTRIBUTORS TO THE DEFECT HAVE BEEN IMMEDIATELY RECTIFIED AFTER THE ROOT CAUSES WERE IDENTIFIED. SUMMARY OF ROOT CAUSE ANALYSIS: THE COMPLAINT SAMPLE WAS 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: NOT APPLICABLE JUSTIFICATION: CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "CHEMO LEAKAGE" ACCORDING TO THE CUSTOMER: "THE PRODUCT WAS FILLED WITH 5-FLUOROURACIL AND A 0.9% NACL SOLUTION ON (B)(6)2023 THE FILLED PUMP WAS CHECKED AND RELEASED. UP UNTIL THEN NO DEFECTS HAD BEEN NOTICED. THE FINISHED PREPARATION WAS DELIVERED TO THE CLINIC. THE STAFF ON SITE CONTACTED US ON JANUARY 17TH. REPORTED THAT THE PUMP HAD LEAKED, BUT THE PREPARATION WAS STILL SEALED SO THAT NO STAFF OR PATIENT CAME INTO CONTACT WITH THE DRUG. THE PREPARATION WAS CONSEQUENTLY NOT ADMINISTERED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1955261 EASYPUMP 2 ELASTOMERIC PUMPS MEB B BRAUN MELSUNGEN AG 4540018-07 22L16GED9R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown