BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 16599620 · Received March 23, 2023

    Report

    Report Number
    9610825-2023-00047
    Event Type
    Malfunction
    Date Received
    March 23, 2023
    Date of Event
    January 20, 2023
    Report Date
    November 13, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. 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 MELSUNGEN AG INTERNAL REPORT # (B)(4). DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 22C02GED81, THERE IS NO ABNORMALITY AND NO SUCH DEFECT DETECTED AT IN PROCESS AND AT FINAL CONTROL INSPECTION. ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: FINAL CONTROL FLOW RATE REPORT OF AFFECTED BATCH 22C02GED81 WAS REVIEWED. FOR FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN (B)(4). AS NO COMPLAINT SAMPLE WAS RECEIVED, FURTHER INVESTIGATION IS NOT POSSIBLE. 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 2 ML/HR TO 2.36 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 ACCORDING TO IFU. SUMMARY OF ROOT CAUSE ANALYSIS: AS NO COMPLAINT SAMPLE WAS RECEIVED, FURTHER INVESTIGATION IS NOT POSSIBLE. THEREFORE, THIS COMPLAINT IS CONSIDERED AS NOT CONFIRMED. CAUSE: CAUSE COULD NOT BE DETERMINED. JUSTIFICATION: NOT CONFIRMED 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 (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN BRAZIL: "OVERINFUSION". ACCORDING TO THE CUSTOMER: "THE PUMP WAS EMPTIED OUTSIDE THE SCHEDULED TIME. 08 HOURS BEFORE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739994 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 22C02GED81

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown