BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 21796296 · Received April 8, 2025

    Report

    Report Number
    9610825-2025-00230
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    March 13, 2025
    Report Date
    April 22, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT 6: 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905.

    Additional Manufacturer Narrative · 0

    EVENT 6 THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4). PREMARKET SUBMISSION # K081905. DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 24H26GED91, THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. SAMPLE EVALUATION: RECEIVED 2 SAMPLES OF EASYPUMP II LT 270-54-S-EU/SA WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF BOTH SAMPLES WAS 24H26GED91. IT WAS REPORTED THAT THESE SAMPLES WERE USED TO BE FILLED WITH 5-FU. INVESTIGATION RESULTS: THE FLOW RATE REPORT OF AFFECTED BATCH 24H26GED91 WAS REVIEWED. REVIEWED FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN 2.33% AND 9.77%. NO ABNORMALITY WAS OBSERVED. BOTH RECEIVED SAMPLE WERE WEIGHED AND SAMPLE 1 WAS RECORDED AT 74.19 G MEANWHILE THE SAMPLE 2 WAS RECORDED AT 88.17 G. THE AVERAGE WEIGHT OF AN UNFILLED EASYPUMP II FOR THIS ARTICLE IS 75 G AND THE RETAINED VOLUME SHOULD BE #8ML. THEREFORE, THE FIRST PUMP HAS BEEN EMPTIED WHILE THE SECOND PUMP CONTAINED SOME CLEAR SOLUTION IN IT UPON RECEIVING. DURING VISUAL INSPECTION, SAMPLE 1 WAS OBSERVED TO HAVE WHITE CRYSTALLIZATION IN THE MICROBORE TUBE. THE SAMPLE WAS FILLED WITH SOME SOLUTION TO CONFIRM THE FLOW IS BLOCKED. NO FLOW WAS OBSERVED AFTER UNCLAMPED. THE BLOCKAGE WAS DUE TO THE FORMATION OF DRUG CRYSTALLIZATION OBSERVED ALONG THE TUBES OF THE PUMP. THERE ARE SOME DRUGS (E.G. 5FU, CEFEPIME) WHICH TEND TO CRYSTALLIZE AT SOME SPECIAL CONDITION AND WILL CAUSE BLOCKAGE ON THE PATH OF THE SOLUTION. THUS, WHEN THE SAMPLES WERE BLOCKED, FURTHER INVESTIGATION FOR FLOW RATE WAS NOT POSSIBLE. ON THE OTHER HAND, SAMPLE 2 WAS SENT FOR DECONTAMINATION. THE FLOW RATE DEVIATION FROM NOMINAL FLOW RATE FOR RECEIVED SAMPLE WAS -2.23%, WITHIN THE SPECIFICATION OF ±15%. HOWEVER, THERE ARE SOME POSSIBILITIES THAT CAUSE 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 5ML/HR TO 5.9ML/HR. 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. 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. FOLDED OUTER SHELL WILL ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. CONCLUSION: ONE SAMPLE WAS BLOCKED AT THE MICROBORE TUBE DUE TO DRUG PRECIPITATION. THUS, FURTHER INVESTIGATION TO CONFIRM THAT FAST FLOW RATE WAS NOT POSSIBLE. ON THE OTHER HAND, ANOTHER SAMPLE WAS TESTED AND PASSED THE FLOW RATE TEST. HENCE, WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED.

    Description of Event or Problem · 0

    EVENT 6: ACCORDING TO THE EVENT DESCRPTION: THE PUMP WAS PREFILLED WITH 5FU. THE PUMP EMPTIED IN 39 HOURS AND 30 MINUTES INSTEAD OF 54 HOURS. 6 PATIENTS SUFFERED EXACTLY THE SAME. PATIENTS AGED 62-65 YEARS, NO SIDE EFFECTS SO FAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585111 EASYPUMP 2 PUMP, INFUSION, ELASTOMERIC MEB B BRAUN MELSUNGEN AG 4540018-07 24H26GED91

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown