BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18161242 · Received November 17, 2023

    Report

    Report Number
    9610825-2023-00534
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Date of Event
    October 24, 2023
    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 MEDICAL INTERNAL REPORT NUMBER (B)(4). ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: RECEIVED 3 SAMPLES WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER FOR AL THE COMPLAINT SAMPLES WERE 22L01GED8R. ALL 3 COMPLAINT SAMPLES WERE FILLED WITH SOLUTION AND BBC (BIG BOTTOM CAP) WAS REMOVED. LEAKAGE WAS OBSERVED AT ALL 3 SAMPLES AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. MEASURE: ASSEMBLY OF THE REWORK COMPLAINT BATCH WAS DONE ACCORDING TO SOP ELASTOMERIC INFUSION SYSTEM - FINAL ASSEMBLY (HC-MY01-M-5-4-16-015-0, VERSION 34.0) AND SOP ELASTOMERIC INFUSION SYSTEM - CORRECTION PROCEDURE. ANALYSIS: THIS COMPLAINT BATCH (22L01GED8R) WAS REWORKED BATCH OF 22L01GED81 WITH HOLDBACK AT FINAL CONTROL INSPECTION ON FAILED TIGHTNESS TEST (LEAKED BETWEEN STEP DOWN TUBE AND TRIANGLE TUBE AT BIG BOTTOM CAP). THE HOLDBACK BATCH WAS REWORKED ACCORDING TO SOP HC-MY01-M-5-4-16-021-0 WHERE THE OLD STEP DOWN TUBE AND TUBING WERE REMOVED AND REPLACED WITH THE NEW STEP DOWN TUBE, TRIANGLE TUBE AND MICROBORE TUBE. 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 IS IN PLACE TO FURTHER ADDRESS ISSUES WITH LEAKAGE. SUMMARY OF ROOT CAUSE ANALYSIS: ALL 3 SAMPLES WERE LEAKING AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. THUS, WE CONSIDERED THIS COMPLAINT AS CONFIRMED. AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH LEAKAGE. CAUSE : FAILURE IN PRODUCTION PROCESS JUSTIFICATION: CONFIRMED. 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "CHEMO LEAKAGE" ACCORDING TO THE CUSTOMER: "THREE 5-FU INFUSION PUMPS OF THE SAME BATCH HAVE LEAKED/LEAKED. TWO DEFECTIVE PUMPS WERE DELIVERED TO THE STATION. THE FIRST PUMP HAS LEAKED TO THE PATIENT DURING APPLICATION. THE SECOND PUMP WAS STILL IN THE SEALED BAG WHEN LIQUID LEAKED. A THIRD PUMP RAN OUT DURING THE MANUFACTURING PROCESS. THE DROPS APPEAR CLEARLY ON THE PHOTOS AT THE CONNECTION POINT OF THE PUMP TO THE HOSE UNDER THE WHITE CAP. NO PATIENT AND STAFF WERE ACUTELY INJURED, BUT IN SKIN CONTACT WITH THE CYTOSTATIC AGENT. THERAPIES HAD TO BE POSTPONED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1744310 EASYPUMP 2 ELASTOMERIC INFUSION PUMP MEB B BRAUN MELSUNGEN AG 4540016-07 22L01GED8R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown