BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 7324485 · Received March 8, 2018

    Report

    Report Number
    9610825-2018-00038
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    November 23, 2017
    Report Date
    August 13, 2018
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    UDI-DI
    04046964448638
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018 B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). "THE DEVICE IS CURRENTLY ON SHIPPING FROM COLOMBIA TO BBM IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE." A REVIEW OF THE BATCH AND MANUFACTURING RECORDS REVEALED NO ABNORMALITIES OR NONCONFORMITIES.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2016018. (B)(4). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) INTERNAL REPORT # (B)(4). WE RECEIVED ONE USED, FILLED (WITH APPROXIMATELY 20 ML CYTOSTATIC AGENT) EASYPUMP II LT 270-54-S WITHOUT PACKAGING, CONNECTED WITH A CANNULA OF A COMPETITOR. THE PROVIDED SAMPLE WAS SUBJECTED TO A VISUAL EXAMINATION. DAMAGES THAT WOULD LEAD TO THE REPORTED MALFUNCTION WERE NOT DETECTED AT THE SAMPLE. IN ADDITION, THE SAMPLE WAS FILLED UP TO THE NOMINAL VALUE (270 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER REMOVING THE CANNULA, OPENING THE CLAMP CLIP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED AT THE SAMPLE. BECAUSE THE SAMPLE IS BLOCKED A TOO FAST FLOW (AS DESCRIBED BY THE CUSTOMER) COULD NOT BE DETERMINED AT THE INSPECTED SAMPLE. THE SAMPLE WILL BE SENT TO THE MANUFACTURER (B. BRAUN MEDICAL INDUSTRIES). BMI STATEMENT: SUMMARY OF ROOT CAUSE ANALYSIS: SINCE THE COMPLAINT SAMPLE WAS BLOCKED, FURTHER INVESTIGATION ON FLOW RATE WAS NOT POSSIBLE. HOWEVER, THE BLOCKAGE OF THE SAMPLE WAS POSSIBLY DUE TO THE DRUG CRYSTALLIZE RESIDUES ON THE FLOW PATH OF THE SOLUTION. THERE ARE SOME DRUGS (E.G. 5FU) WHICH TEND TO CRYSTALLIZE AT SOME SPECIAL CONDITION. THE RISK OF CRYSTALLIZATION IS GIVEN BY THE DRUG ITSELF. SOME FUNCTION OF PUMP (FILTER, MICROBORE, ETC) MAY BE AFFECTED WHEN A HIGH AMOUNT OF CRYSTALLIZE PARTICLE FORMS FROM THE DRUG.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN COLOMBIA: FASTER INFUSION RATE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166921 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 16M17GE271 04046964448638

    Patients

    Seq Age Sex Outcome Treatment
    1