BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP

    MDR report key: 17540148 · Received August 14, 2023

    Report

    Report Number
    9610825-2023-00369
    Event Type
    Malfunction
    Date Received
    August 14, 2023
    Report Date
    April 24, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 INFORMATION: H6 CODES UPDATED ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: RECEIVED A SAMPLE OF EASYPUMP II LT 125-25-S-EU/SA WITHOUT ORIGINAL PACKAGING. BATCH NUMBER ON THE BIG BOTTOM CAP WAS 22M10GED31. AS RECEIVED CONDITION, THE SAMPLE WAS NOT CLAMPED, AND A RED CONE WAS ATTACHED. UPON VISUAL INSPECTION, A CRACK WAS OBSERVED AT THE FILLING PORT. BASED ON THE CUSTOMER DESCRIPTION, "POSSIBLY, THERE WAS A MICRO-HOLE ON THE BAG" WAS MENTIONED. HOWEVER, DURING INVESTIGATION, THERE WAS NO ABNORMALITY OR WATER DROPLETS OBSERVED FROM THE PUMP. THE "MICRO-HOLE" MENTIONED COULD BE THE PUNCHING HOLE OF THE OUTER SLEEVE, WHICH WOULD NOT CAUSE LEAKAGES. ACCORDING TO ELASTOMERIC INFUSION SYSTEM - FINAL ASSEMBLY PROCESS SOP (HC-MY01-M-5-4-16-015-0; VERSION 37.0; CLAUSE 6.3.4), THERE ARE 2 PUNCHING HOLES AT THE BOTTOM SIDE OF THE OUTER SLEEVE. THE HOLES IN THE OUTER SLEEVE ARE FOR AIR MOVEMENT WHEN THE INNER MEMBRANE OF THE PUMP IS EXPANDING AND DEFLATING. TO CHECK FOR LEAKAGE, THE SAMPLE WAS FILLED WITH RED DYE SOLUTION AND PLACED ON A PAPER FOR BETTER VISUAL OF THE DEFECT MENTIONED. HOWEVER, UPON REMOVAL OF THE RED CONE, THE SOLUTION WAS SEEN TO FLOW OUT OF THE PATIENT CONNECTOR ONLY. WHEN LEAVE OVERNIGHT WITH RED CONE CONNECTED AND CLAMP CLIP RELEASED, THERE ARE NO LEAKAGES OBSERVED FROM THE TUBE CONNECTIONS, VALVE AREA, SILICON SLEEVES, AND FILTER. FIGURE 6 AND 7: NO LEAKAGES OBSERVED. SUMMARY OF ROOT CAUSE ANALYSIS: THE FAILURE MODE AS DESCRIBED CANNOT BE JUSTIFIED, THEREFORE WE CONSIDER THIS COMPLAINT AS NOT CONFIRMED. CAUSE : CAUSE COULD NOT BE DETERMINE CORRECTIONS/CONTAINMENT PLANS WITH EFFECTIVE DATE: NOT APPLICABLE CORRECTIVE ACTIONS WITH EFFECTIVE DATE: NOT APPLICABLE JUSTIFICATION: NOT CONFIRMED ROOT CAUSE ANALYSIS: SAMPLE/S EVALUATION: RECEIVED A SAMPLE OF EASYPUMP II LT 125-25-S-EU/SA WITHOUT ORIGINAL PACKAGING. BATCH NUMBER ON THE BIG BOTTOM CAP WAS 22M10GED31. AS RECEIVED CONDITION, THE SAMPLE WAS NOT CLAMPED, AND A RED CONE WAS ATTACHED. COMPLAINT SAMPLE AS RECEIVED CONDITION. UPON VISUAL INSPECTION, A CRACK AND LEAKAGE WERE OBSERVED FROM THE CRACK DURING FILLING. BASED ON THE CUSTOMER DESCRIPTION, "POSSIBLY, THERE WAS A MICRO-HOLE ON THE BAG" WAS MENTIONED. CRACK AT FILLING PORT IS A KNOWN ISSUE AND AN APPROVED PROJECT HAS BEEN INITIATED TO ADDRESS THE CRACK ISSUE AT FILLING PORT. AFFECTED CAP VALVE CAVITY NUMBER AS BELOW: ITEM CAVITY NUMBER CAP VALVE OF THE SAMPLE A8. SUMMARY OF ROOT CAUSE ANALYSIS: THE COMPLAINT SAMPLE WAS FOUND CRACK AT FILLING PORT. HENCE, THIS COMPLAINT IS CONFIRMED.

    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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN GERMANY: "CHEMO LEAKAGE" ACCORDING TO THE CUSTOMER: "WAS THERE A PATIENT HAZARD OR DID THE LEAKAGE ALREADY OCCUR DURING PREPARATION? NO AND NO: THERE WAS NEITHER A PATIENT HAZARD NOR DID THE LEAK OCCUR DURING MANUFACTURE (PREPARATION): THE LEAK WAS DETECTED SHORTLY BEFORE APPLICATION IN THE PHYSICIAN'S OFFICE. THE PREPARATION WAS NOT ADMINISTERED TO THE PATIENT DUE TO THE LEAKAGE. NO LEAKAGE WAS OBSERVED DURING MANUFACTURE AND THE FINAL INSPECTION THAT IMMEDIATELY FOLLOWED, OTHERWISE THE PREPARATION WOULD NOT HAVE BEEN RELEASED AND DELIVERED TO THE PHYSICIAN'S OFFICE. POSSIBLY, THERE WAS A MICRO-HOLE ON THE BAG CAUSED BY THE B-BROWN MANUFACTURING PROCESS OF THE BAG WHICH ENLARGED AFTER FILLING (MANUFACTURING OF THE PREPARATION) ON THE TRANSPORT ROUTE FROM US (MANUFACTURE) TO THE PHARMACY OR TO THE DOCTOR'S OFFICE? THIS SHOULD PLEASE BE DETERMINED AS PART OF THE CAUSE INVESTIGATION BY B. BRAUN"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1354776 EASYPUMP ELASTOMERIC INFUSION PUM MEB B BRAUN MELSUNGEN AG 22M10GED31

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown