BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18436523 · Received January 3, 2024

    Report

    Report Number
    9610825-2023-00635
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    December 6, 2023
    Report Date
    May 3, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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: DEVICE HISTORY RECORD (DHR):- REVIEWED THE DHR FOR BATCH 22L01GED8R, WHICH WAS A REWORKED BATCH FOR 22L01GED81 WITH HOLDBACK AT FINAL CONTROL INSPECTION ON FAILED TIGHTNESS TEST (LEAKED BETWEEN STEP DOWN TUBE AND TRIANGLE TUBE AT BIG BOTTOM CAP). REWORK WAS PERFORMED ON THE BATCH ACCORDING TO SOP HC-MY01-M-5-4-16-021-0. AFTER REWORKED, NO SUCH DEFECT WAS DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION, THEREFORE, THIS BATCH WAS RELEASED. SAMPLE/S EVALUATION: RECEIVED 1 SAMPLE WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BBC (BIG BOTTOM CAP) OF THE COMPLAINT IS 22L01GED8R. THE COMPLAINT SAMPLE WAS FILLED WITH SOLUTION AND BBC WAS REMOVED. LEAKAGE WAS OBSERVED AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH LEAKAGE. ANALYSIS: THE COMPLAINT BATCH 22L01GED8R WAS A REWORKED BATCH WITH HOLDBACK AT FINAL CONTROL INSPECTION ON FAILED TIGHTNESS TEST DUE TO LEAKED BETWEEN STEP DOWN TUBE AND TRIANGLE TUBE CONNECTION. REWORK WAS PERFORMED ACCORDING TO SOP HC-MY01-M-5-4-16-021 WHERE THE OLD STEP DOWN TUBE AND TUBING WAS CREMOVED AND REPLACED WITH NEW STEP DOWN TUBE, TRIANGLE TUBE, AND MICROBORE TUBE. ASSEMBLY OF THE REWORK COMPLAINT BATCH WAS DONE ACCORDING TO SOP ELASTOMERIC INFUSION - FINAL ASSEMBLY PROCESS (HC-MY01-M-5-4-16-015-0, VERSION 34.0) AND SOP ELASTOMERIC INFUSION SYSTEM - CORRECTION PROCEDURE AFTER THE BATCH WAS REWORKED, IT WAS TESTED ACCORDING TO SPECIFICATION (HC-MY01-M-5-4-10-601-0) AND RELEASE AFTER THE PRODUCT ARE TESTED TO BE WITHIN SPECIFICATION. THE REWORK PROCESS WILL NOT HAVE ADVERSE EFFECT TO THE PUMP. HOWEVER, DURING THE REWORK, THE ROOT CAUSE OF THE COMPLAINT DEFECT WAS STILL UNDER INVESTIGATION. UPON THE ROOT CAUSE WERE IDENTIFIED, MITIGATION ACTIONS HAVE BEEN IMPLEMENTED TO ADDRESS THE ISSUE. THE MAJOR CONTRIBUTORS OF 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. AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH LEAKAGE. CAUSE : FAILURE IN PRODUCTION PROCESS 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 SWITZERLAND: "CHEMO LEAKAGE". ACCORDING TO THE COMPLAINANT AFTER FILLING THE PUMP, A WET SPOT WAS NOTICED ON THE PATIENT'S TROUSERS AND THIGH (UNDER THE EASYPUMP). THE CHECK REVEALED THAT THE FLUOROURACIL HAD ESCAPED THROUGH A LEAK DIRECTLY AT THE TRANSITION FROM THE HOUSING TO THE CONNECTING TUBE. IT WAS STOPPED IMMEDIATELY AND THE SKIN AREA WAS PHOTOGRAPHED. SMALL DOTS WERE VISIBLE, BUT IT WAS UNCLEAR WHETHER THEY HAD BEEN THERE BEFORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1435226 EASYPUMP 2 ELASTOMERIC INFUSION PUMP MEB B BRAUN MELSUNGEN AG 4540016-07 22L01GED8R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown