BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 19220403 · Received May 1, 2024

    Report

    Report Number
    9610825-2024-00324
    Event Type
    Malfunction
    Date Received
    May 1, 2024
    Date of Event
    March 4, 2024
    Report Date
    November 14, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    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 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 ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    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. CORRECTED INFORMATION: D4 PRIMARY UNIQUE DEVICE IDENTIFIER (UDI) NUMBER H5 DEVICE LABELED FOR SINGLE USE UPDATED INFORMATION: D9 DEVICE RETURNED TO MANUFACTURER DEVICE HISTORY RECORD (DHR): REVIEWED THE DHR FOR BATCH 22L13GED91, THERE WAS NO DEFECT ENCOUNTERED DURING IN PROCESS AND FINAL CONTROL INSPECTION. 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 SAMPLE WAS 22L13GED91. UPON RECEIVED, NO SOLUTION WAS OBSERVED IN THE SAMPLE AND THE SAMPLE WAS CLAMPED. ITS FILLING PORT WAS CLOSED WITH DISCOFIX CAP, WHEREAS ITS PATIENT CONNECTOR WAS NOT CLOSED WITH WING CAP. SOME WHITE PRECIPITATION WAS FOUND AT THE FILLING PORT AND WITHIN THE TUBING OF THE SAMPLE. INVESTIGATION RESULTS: THE FLOW RATE REPORT OF AFFECTED BATCH 22L13GED91 WAS REVIEWED. FOR FINAL CONTROL FLOW RATE REPORT, THE AVERAGE FLOW RATE THE RECEIVED SAMPLE WAS WEIGHED AND RECORDED AT 78.02. AN UNFILLED EASYPUMP FOR THIS ARTICLE TYPICALLY WEIGHS 75G, AND THE RETAINED VOLUME SHOULD BE #3G. THIS INDICATES THAT THE RECEIVED SAMPLE WAS EMPTIED. THE SAMPLE WAS DECONTAMINATED AND SENT FOR FLOW RATE TEST. THE FLOW RATE DEVIATION FROM NOMINAL FLOW RATE FOR RECEIVED SAMPLE WAS -3.60%. THE FLOW RATE OF THE 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 AS 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 5.9 ML/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: FOLDED OUTER SHELL ACCORDING TO IFU, THE OUTER LAYER HAS TO BE UNFOLDED PROPERLY PRIOR TO FILLING. FOLDED OUTER SHELL WILL ACT AS THE EXTERNAL PRESSURE TO ELASTOMERIC MEMBRANE AND INCREASE THE FLOW RATE OF THE PRODUCT. CONCLUSION: SINCE THE FLOW RATE OF RECEIVED SAMPLE WAS WITHIN THE SPECIFICATION, HENCE WE CONSIDERED THIS COMPLAINT AS NOT CONFIRMED.

    Description of Event or Problem · 0

    ACCORDING TO THE CUSTOMER THE MEDICINE WAS INFUSED IN LESS TIME THAN PROGRAMMED. REPORTEDLY THE PUMP WAS SCHEDULED TO RUN IN 48 HOURS AND MERGED IN 38 HOURS

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2138304 EASYPUMP 2 ELASTOMERIC PUMPS MEB B BRAUN MELSUNGEN AG 4540018-07 22L13GED91 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown