BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18282608 · Received December 7, 2023

    Report

    Report Number
    9610825-2023-00570
    Event Type
    Malfunction
    Date Received
    December 7, 2023
    Date of Event
    November 7, 2023
    Report Date
    December 7, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RP
    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). 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. BMI COMPLAINT MANAGEMENT STATEMENT:- DEVICE HISTORY RECORD (DHR):- REVIEWED THE DHR FOR BATCH 22L04GE27R, THERE IS NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION PERTAINING PRODUCT WITH FLOW RATE ISSUE. 2 PICTURES WERE PROVIDED IN THE CC NOTIFICATION SHOWING A SAMPLE OF EASYPUMP II LT 270-54-S INSIDE PLASTIC BAG, WHICH WAS WRAPPED WITH BLACK PLASTIC. A MEDICATION LABEL WAS ATTACHED ON THE BLACK PLASTIC. KINDLY REFER TO THE PICTURES ATTACHED IN THE CC NOTIFICATION. SAMPLE RECEIPT AT BMI - COMPLAINT MANAGEMENT, DATED: 2023-11-14 SAMPLE EVALUATION:- RECEIVED 1 SAMPLE OF EASYPUMP II LT 270-54-S WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF THE SAMPLE WAS 22L04GE27R. UPON RECEIVED, NO SOLUTION WAS FOUND IN THE SAMPLE, AND THE CLAMP OF THE SAMPLE WAS CLOSED WITHOUT CLAMPING ON THE TUBE OF THE SAMPLE. IT WAS REPORTED THAT THE SAMPLE WAS USED TO BE FILLED WITH 5-FU AND HEPARIN. ITS FILLING PORT WAS CLOSED WITH DISCOFIX CAP, WHEREAS ITS PATIENT CONNECTOR WAS NOT CLOSED WITH WING CAP. REFER TO THE PICTURE ATTACHED IN THE PC NOTIFICATION. COMPLAINT AND SAMPLE TO BE FORWARDED TO INVESTIGATOR FOR FURTHER INVESTIGATION. OBJECTPART FLOW RATE. TASK FOR (B)(6): REVIEW OF BATCH HISTORY RECORDS. STATUS: TASK COMPLETED. DHR REVIEWED. TASK FOR (B)(6): SAMPLES RECEIPT AT BMI. STATUS: TASK COMPLETED. SAMPLE RECEIVED: 2023-11-14. TASK FOR (B)(6): AWAITING STATEMENT: STATUS: TASK COMPLETED. ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: THE AFFECTED BATCH WAS HOLD BACK AT FINAL CONTROL DUE TO LEAKING AT BIG BOTTOM CAP. THE BATCH WAS THEN REWORKED UNDER SOP ELASTOMERIC INFUSION SYSTEM - CORRECTION PROCEDURE (HC-MY01-M-5-4-16-021-0), CLAUSE 6.5.1.7 REWORK METHOD: ALL OPEN PACKAGE REWORK. UNDER THIS REWORK METHOD, NEW FLOW RESTRICTOR INCLUDING NEW FILTER WAS REPLACED TO THE PUMP. AFTER REWORK PROCESS, THE BATCH WAS TESTED AS PER IN-PROCESS (DOC. NO.: HC-MY01-M-5-4-10-407-0) AND FINAL CONTROL (DOC. NO.: HC-MY01-5-4-10-601-0) SPECIFICATION. THE BATCH WAS RELEASED PASSED ALL TEST, WHICH INCLUDING FLOW RATE TEST. THE FLOW RATE REPORT OF AFFECTED BATCH 22L04GE27R WAS REVIEWED. FOR FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN -2.52% AND 1.80%. RECEIVED 1 USED AND FILLED EASYPUMP II LT 270-54-S. AS RECEIVED CONDITION, THE CLAMP CLIP OF RECEIVED SAMPLE WAS CLAMPED, AND NO WING CAP WAS CONNECTED TO THE PATIENT CONNECTOR. REFER FIGURE 1. FIGURE 1: SAMPLE AS RECEIVED CONDITION. VISUAL INSPECTION HAD DONE THROUGHOUT THE RECEIVED SAMPLE. NO ABNORMALITY WAS OBSERVED. THE SAMPLE WAS DECONTAMINATED AND SENT FOR FLOW RATE TEST (LTCA-CXU4YF)). THE FLOW RATE DEVIATION FROM NOMINAL FLOW RATE FOR RECEIVED SAMPLE WAS -1.93%. THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION ±15% DEVIATION FROM NOMINAL FLOW RATE. REFER FIGURE 2. FIGURE 2: FLOW RATE RESULT: HOWEVER, THERE ARE SOME POSSIBILITIES THAT TO CAUSE THE FAST FLOW RATE TO OCCUR DURING APPLICATION, SUCH THAT ONE OR COMBINATION FACTORS ARE LISTED AS BELOW: FACTOR 1: TEMPERATURE: THE TEMPERATURE OF THE SURROUNDING WILL AFFECT THE FLOW RATE OF THE SAMPLE. FOR EVERY INCREASE OF 1°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE APPROXIMATELY BY 3%. FOR EXAMPLE, IF THE FLOW RESTRICTOR OF THE PRODUCT REACHES THE TEMPERATURE OF 37°C, THE FLOW RATE OF THE SAMPLE WILL INCREASE BY APPROXIMATELY 18% WHICH MEANS THE FLOW RATE WILL INCREASE FROM 5 ML/HR TO 5.9ML/HR. REFER FIGURE 3. FIGURE 3: IFU STATEMENT. FACTOR 2: EXTERNAL PRESSURE: EXTERNAL PRESSURE SUCH AS SQUEEZING OR LAYING ON THE PUMP WILL INCREASE THE FLOW RATE WHICH CAUSE THE PUMP TO EMPTY EARLIER THAN THE NOMINAL TIME. REFER FIGURE 4. FIGURE 4: IFU STATEMENT. SIMULATION OF EXTERNAL PRESSURE HAD BEEN CONDUCTED. THE FLOW RATE OF THE PRODUCT CAN INCREASE WHEN EXTERNAL FORCE IS APPLIED TO THE PUMP. HOWEVER, THIS EXTERNAL FORCE IS AGAINST THE INTENDED USE OF THE PRODUCT ACCORDING TO IFU. FACTOR 3: FOLDER OUTER SHELL ACCORDING TO IFU, THE OUTER LAYER HAS TO BE UNFOLDED PROPERLY PRIOR FILLING. REFER FIGURE 5. FOLDED OUTER SHELL WILL ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. FIGURE 5: IFU STATEMENT. SUMMARY OF ROOT CAUSE ANALYSIS: SINCE THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION, HENCE WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED. CAUSE : CAUSE COULD NOT BE DETERMINE. THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION AFTER SENT FOR FLOW RATE TEST, WHICH IS ACCORDING TO TEST METHOD 116008 UNDER LAB CONDITION. CORRECTIONS/CONTAINMENT PLANS WITH EFFECTIVE DATE: NOT APPLICABLE. CORRECTIVE ACTIONS WITH EFFECTIVE DATE: NOT APPLICABLE. JUSTIFICATION: NOT CONFIRMED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN THE PHILIPPINES: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "CHEMOTHERAPY ORDER WAS 5FU 3000MG IV IN 230ML NSS + 2ML HEPARIN TO RUN FOR 46HRS, PATIENT COMPLAINED IT DIDN'T LAST FOR 46 HOURS, BUT IT TOOK 36 HOURS. INCIDENT HAPPENED 3 TIMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1128632 EASYPUMP 2 ELASTOMERIC INFUSION PUMP MEB B BRAUN MELSUNGEN AG 4540018 22L04GE27R

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown