BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18360167 · Received December 19, 2023

    Report

    Report Number
    9610825-2023-00595
    Event Type
    Malfunction
    Date Received
    December 19, 2023
    Date of Event
    November 23, 2023
    Report Date
    March 14, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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 1 SAMPLE WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BBC (BIG BOTTOM CAP) OF THE COMPLAINT SAMPLE IS (B)(6). THE COMPLAINT SAMPLE WAS FILLED WITH SOLUTION AND BBC WAS REMOVED. LEAKAGE WAS OBSERVED AT TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION. 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 THE OLD STEP DOWN TUBE AND TUBING WAS REMOVED 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 (DOCUMENT NO: HC-MY01-M-5-4-16-021-0, VERSION 17.0) AFTER THE BATCH WAS REWORKED, IT WAS TESTED ACCORDING TO SPECIFICATION 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 TRIANGLE TUBE TO STEP DOWN TUBE CONNECTION LEAKAGE. 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). 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

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN PORTUGAL: "CHEMO LEAKAGE" ACCORDING TO THE COMPLAINANT AFTER THE PATIENT STARTED THERAPY WITH THE PUMP, IT WAS FOUND THAT THERE HAD BEEN A LEAKAGE OF THE CYTOSTATIC DRUG IN THE TRANSPORT BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2118084 EASYPUMP 2 ELASTOMERIC INFUSION PUMP MEB B BRAUN MELSUNGEN AG 4540016-07 22L01GED8R

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown