BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 21696920 · Received March 26, 2025

    Report

    Report Number
    9610825-2025-00168
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    February 20, 2025
    Report Date
    April 10, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AG
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT 2 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 DEVICES ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # FOR SIMILAR DEVICE: (B)(4).

    Additional Manufacturer Narrative · 0

    EVENT 2 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 DEVICES ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC. PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) # FOR SIMILAR DEVICE: (B)(4). DEVICE HISTORY RECORD (DHR):- REVIEWED THE DHR FOR BATCH 23B23GED91, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE RECEIPT AT BMI - COMPLAINT MANAGEMENT, DATED: 2025-03-10. SAMPLE EVALUATION:- RECEIVED ONE SAMPLE OF EASYPUMP II LT 270-54-S-EU/SA WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF THE RECEIVED SAMPLE WAS 23B23GED91. UPON RECEIVED, NO SOLUTION WAS OBSERVED IN THE SAMPLE AND THE SAMPLE WAS NOT CLAMPED. IT WAS REPORTED THAT THE SAMPLE WAS USED TO BE FILLED WITH 5-FLUOROURACIL. ITS FILLING PORT WAS CLOSED WITH DISCOFIX CAP, WHEREAS ITS PATIENT CONNECTOR WAS WRAPPED BY A PIECE OF COTTON GAUZE. SOME WHITE CRYSTALLIZATION WAS OBSERVED AT THE FILLING PORT, IN THE FILTER, AND IN THE PATIENT CONNECTOR OF THE SAMPLE. FINAL CONTROL FLOW RATE REPORT OF AFFECTED BATCH 23B23GED91 WAS REVIEWED. REVIEWED FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN -5.96% AND 0.65%. NO ABNORMALITY WAS OBSERVED. RECEIVED 1 USED AND FILLED EASYPUMP II LT 270-54-S-EU/SA WITH BATCH NUMBER 23B23GED91. AS RECEIVED CONDITION, THE RECEIVED SAMPLE WAS UNCLAMPED, AND THE WING CAP IS NOT ATTACHED TO THE PATIENT CONNECTOR. THE RECEIVED SAMPLE WAS WEIGHED AT 76.52 G. THE AVERAGE WEIGHT OF AN UNFILLED EASYPUMP II FOR THIS ARTICLE IS 75 G AND THE RETAINED VOLUME SHOULD BE 8ML. THEREFORE, THE PUMP IS EMPTIED UPON RECEIVING. VISUAL INSPECTION HAD DONE THROUGHOUT THE RECEIVED SAMPLE. WHITE CRYSTALLIZE RESIDUE WAS FOUND THROUGHOUT THE FLOW RESTRICTOR OF THE RECEIVED SAMPLE. WHEN FILLED WITH SOLUTION, SOLUTION IS UNABLE TO FLOW OUT FROM THE PATIENT CONNECTOR. AS THE FLOW RESTRICTOR AREA WAS BLOCKED, IT IS NOT POSSIBLE TO CONFIRM THE FLOW RATE OF THE COMPLAINT SAMPLE SINCE THE WHITE CRYSTALLIZE RESIDUES HAS CAUSE THE BLOCKAGE IN THE SAMPLE, FURTHER INVESTIGATION TO DETERMINE THE FLOW RATE WAS NOT POSSIBLE. FAST FLOW RATES CUSTOMER DESCRIPTION COULD NOT BE IDENTIFIED. HOWEVER, THERE ARE SOME POSSIBILITIES THAT CAN CAUSE THE SAMPLE EMPTIES FASTER THAN NOMINAL TIME IN ACTUAL APPLICATION, SUCH AS ONE OR COMBINATION FACTORS OF MORE THAN ONE 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 5.9 ML/HR. FACTOR 2 FOLDED OUTER SHELL (OUTER LAYER) FOLDED OUTER SHELL (OUTER LAYER) WILL ALSO ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. FACTOR 3 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. 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. SUMMARY OF ROOT CAUSE ANALYSIS: FAST FLOW RATE AS PER CUSTOMER DESCRIPTION COULD NOT BE DETERMINED DUE TO BLOCKAGE, THEREFORE WE CONSIDER THIS COMPLAINT AS NOT CONFIRMED. THE BLOCKAGE OF THE SAMPLE WAS DUE TO WHITE CRYSTALIZE RESIDUES PRESENT IN THE FLOW PATH. CAUSE: CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    EVENT 2 ACCORDING TO THE CUSTOMER: "THE EASYPUMP II PUMP WAS PLACED ON 2 ADULT PATIENTS , THE DRUG SOLUTION ADMINISTERED IS 5 FLUOROURACIL FOR A TOTAL VOLUME OF 230 ML ADMINISTERED IN 22 HOURS INSTEAD OF 46 HOURS. NO LEAKAGE OF THE PRODUCT WAS NOTED BY THE PATIENT OR THE NURSE. AFTER CHECKING BY SIMULATION, WE NOTICED THAT NURSES ARE VERY WELL TRAINED ON EASYPUMP II MEDICAL DEVICE. THE 2 PATIENTS ARE IN GOOD PHYSICAL HEALTH BUT ALL HAD SIDE EFFECTS: HOT FLASHES AND RASH THAT DISAPPEARED SAME TIME AS THE PRODUCT WAS ELIMINATED BY THE BODY." DETAILS OF THE TREATMENT : CYTOTOXIC 5- FLUOROURACIL ADMINISTERED , PROTOCOL OF 46 HOURS, FOR A VOLUME OF 230 MILLILITERS (ML).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2098870 EASYPUMP 2 PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 23F20GED91

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown