BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP II

    MDR report key: 15966062 · Received December 13, 2022

    Report

    Report Number
    9610825-2022-00513
    Event Type
    Malfunction
    Date Received
    December 13, 2022
    Date of Event
    November 10, 2022
    Report Date
    November 9, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT 1: 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). 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. ROOT CAUSE ANALYSIS: RECEIVED 1 USED AND FILLED EASYPUMP II LT 400-80-S. SINCE THE SAMPLE IS RECEIVED IN ORIGINAL PACKAGING, THE RECEIVED SAMPLE IS REFERENCE SAMPLE. AS RECEIVED CONDITION, THE CLAMP CLIP OF RECEIVED SAMPLE WAS CLAMPED, AND WING CAP WAS CONNECTED TO THE PATIENT CONNECTOR. VISUAL INSPECTION HAD DONE THROUGHOUT THE RECEIVED SAMPLE. THE BIG TOP CAP OF THE RECEIVED SAMPLE WAS BROKEN. THIS COULD HAPPEN DURING THE TRANSPORTATION. THE SAMPLE WAS SENT FOR FLOW RATE TEST (LTCA-CNNVXQ). THE FLOW RATE DEVIATION FROM NOMINAL FLOW RATE FOR RECEIVED SAMPLE WAS -0.11%. THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION ±15% DEVIATION FROM NOMINAL FLOW RATE. 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 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 FOLDED OUTER SHELL WAS OBSERVED DURING INVESTIGATION. ACCORDING TO IFU, THE OUTER LAYER MUST 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. SUMMARY OF ROOT CAUSE ANALYSIS: SINCE THE FLOW RATE OF RECEIVED SAMPLE (REFERENCE SAMPLE) WAS WITHIN THE SPECIFICATION, WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED. THE FLOW RATE REPORT OF AFFECTED BATCH 22A03GE291 WAS REVIEWED. THE AVERAGE FLOW RATE DEVIATION FROM THE NOMINAL FLOW RATE WAS BETWEEN -8.84% AND -2.51%. JUSTIFICATION: NOT CONFIRMED.

    Description of Event or Problem · 0

    EVENT 1: AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN SAUDI ARABIA: "OVERINFUSION". ACCORDING TO THE CUSOMER: "10 PATIANT RECIVED FOLFOX ( 5-FU ) FOR PLANNED 48 HRS AS PART OF CRC PROTCOL, THEY RETURN TO HOSPITAL AFTER ( 20-24 ) HRS AFTER START OF INFUSION, THE PUMP THAT USED IS ( EASYPUMP // LT 400-80-S ) AND THE FILL VOLUME WAS 250 ML. NO ADVERSE REACTIONS HAPPENED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420785 EASYPUMP II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 22A03GE291

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown