BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP 2

    MDR report key: 18048322 · Received November 1, 2023

    Report

    Report Number
    9610825-2023-00504
    Event Type
    Malfunction
    Date Received
    November 1, 2023
    Report Date
    November 1, 2023
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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). 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. PROBLEM: FUNCTION - TOO HIGH WE RECEIVED ONE USED AND EMPTY EASYPUMP II LT 270-27-S-EU/SA WITHOUT PACKAGING. THE FOLLOWING INVESTIGATIONS WERE CONDUCTED: VISUAL INSPECTION: THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION ACCORDING TEST METHOD - 102002 DAMAGES. DEFINITION OF THE METHOD: DAMAGES ARE VISIBLE CHANGES IN THE ORIGINAL SHAPE OR SURFACE OF PRODUCTS AND PACKAGING CAUSED BY MECHANICAL FORCES AND/OR MANUFACTURING FAULTS. NOMINAL: NO DAMAGE IS ALLOWED THAT ENDANGERS THE PATIENT, IMPEDES THE USE OF THE PART AS INTENDED (E.G. THE IMPAIRMENT OF THE FUNCTION OF A DROP SENSOR), ENDANGERS THE ASSEMBLY OR FUNCTION OF THE COMPONENT, IMPAIRS THE APPEARANCE OF THE COMPONENT. ACTUAL: WEIGHT OF THE SAMPLES WERE-RECEIVED CONDITION: 74.6 G SAMPLE. AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED. THE PATIENT CONNECTOR WAS OPEN AND THE FILLING PORT WAS CLOSED WITH THE CLOSING CONE. FURTHERMORE, WE DETECT SOLUTION AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE) AT THE USED SAMPLE. DAMAGES THAT WOULD LEAD TO A MALFUNCTION WERE NOT DETECTED AT THE RECEIVED SAMPLE. FUNCTIONAL INSPECTION: AFTERWARDS THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. THEREFORE, THE PUMP WAS APPROXIMATELY FILLED UP TO THE NOMINAL VOLUME OF 270 ML WITH NACL 0.9 %. AFTER STARTING THE PUMP, THE PUMP WORKED IMMEDIATELY (SOLUTION WAS RUNNING). LEAKAGES WERE NOT DETECTED AT THE RECEIVED SAMPLE. PHYSICAL INSPECTION: FURTHERMORE, THE FLOW RATE OF THE PUMP WAS TESTED. NOMINAL: 10 ML/H ACTUAL: 17.1 ML IN 1 H; 28.7 ML IN 2 HRS; 157.7 IN 16,5 HRS. THE DECISIVE VALUE TO EVALUATE THE FLOW RATE WILL BE MEASURED APPROX. AT THE HALF OF THE PUMP RUNNING TIME. THE FLOW RATE OF THE PUMP IS WITHIN THE SPECIFICATION. SUMMARY AND ASSESSMENT: A TOO FAST FLOW OF THE PUMP (AS DESCRIBED BY THE CUSTOMER) COULD NOT BE DETERMINED BY HC-PM COMPLAINT PROCESSING. BASED ON THE CONDUCTED INVESTIGATIONS THE TESTED SAMPLE IS WITHIN THE SPECIFICATION. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. THE INVESTIGATION SAMPLE IS FORWARDED TO MANUFACTURING SITE (B. BRAUN MEDICAL INDUSTRIES).BMI COMPLAINT MANAGEMENT STATEMENT:- SAMPLE RECEIPT AT BMI - COMPLAINT MANAGEMENT, DATED: 2023-10-26. SAMPLE EVALUATION:- RECEIVED ONE SAMPLE OF EASYPUMP II LT 270-27-S-EU/SA WITHOUT ORIGINAL PACKAGING. THE BATCH NUMBER ON THE BIG BOTTOM CAP OF THE SAMPLE WAS 22K13GED41. UPON RECEIVED, SOME CLEAR SOLUTION WAS FOUND REMAINED 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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN NETHERLANDS: "OVERINFUSION" ACCORDING TO THE CUSTOMER: "THESE ARE MULTIPLE EASYPUMPS THAT HAVE ALL BEEN RUN IN BETWEEN 14 AND 18 HOURS. EASYPUMP IS NEXT TO THE BED AT NIGHT ON A NIGHTSTAND. THE FLOW RESTRICTOR IS ATTACHED TO THE SKIN WITH 1 SMALL PATCH. PATIENT HAS NO FEVER. THE PUMP IS REMOVED FROM THE REFRIGERATOR 8 HOURS IN ADVANCE. THE NURSE IS RESPONSIBLE FOR CONNECTING AND DISCONNECTING IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2198854 EASYPUMP 2 ELASTOMERIC INFUSION PUMP MEB B BRAUN MELSUNGEN AG 4540008-07 22K13GED41

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown