BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5370649 · Received January 15, 2016

    Report

    Report Number
    9610825-2015-00701
    Event Type
    Malfunction
    Date Received
    January 15, 2016
    Report Date
    December 22, 2015
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. B. BRAUN MEDICAL, INC. (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF B. BRAUN MELSUNGEN A(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). STATEMENT FROM MANUFACTURER: DEFINE: RECEIVED ONE PIECE OF USED, APPROXIMATELY FULLY FILLED OF EASYPUMP II LT 270-54-S IN OPEN PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP WAS CLOSED AND WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. BIG TOP CAP WAS OPENED AND FILLING PORT WAS CLOSED WITH DISCOFIX CAP. RESIDUE OF THE SOLUTION WAS NOT DETECTED AT THE FILLING PORT. CRYSTALLIZED RESIDUE WAS OBSERVED AT THE FILTER AND TUBING.CRYSTALLIZED RESIDUE ALSO OBSERVED AT THE TUBING NEAR PATIENT CONNECTOR AND LUMEN OF THE GLASS TUBE AT PATIENT CONNECTOR.CLAMP CLIP OF THE RETURNED SAMPLE WAS OPENED AND LEFT FOR 10 MINUTES, SOLUTION WAS NOT FLOWING. SINCE THE RETURNED SAMPLE WAS CONTAMINATED WITH CYTOTOXIC DRUG (5FU), DE-CONTAMINATION PROCESS WAS CARRIED OUT IN ORDER TO PROCEED FOR FURTHER INVESTIGATION. ANALYSIS: FLOW RATE TEST WAS CARRIED OUT. FLOW RATE TEST RESULT IS PASSED, WITH MEAN FLOW RATE OF 4.50 ML/HR (-10.02% DEVIATION FROM NOMINAL FLOW RATE OF 5 ML/HR). NO ABNORMALLY TREND WAS OBSERVED FROM THE FLOW RATE PATTERN. SLOW FLOW RATE CANNOT BE RE-PRODUCEABLE DURING WATER FLOW RATE TEST AT BMI. SLOW FLOW RATE ISSUE THAT ENCOUNTERED BY THE PATIENT COULD BE POSSIBLY DUE TO THE EXISTENCE OF CRYSTALLIZED RESIDUE DURING TREATMENT WHICH SLOW DOWN THE FLOW, AND IT BECAME BLOCKED WHEN ARRIVED BBM. AFTER FLUSHED OUT THE CRYSTALLIZED RESIDUE DURING DE-CONTAMINATION PROCESS, THE WATER FLOW RATE IS TESTED TO BE PASSED. CONCLUSION: THE SLOW FLOW RATE COMPLAINT IS NOT JUSTIFIED. JUSTIFICATION: NOT JUSTIFIED.

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER E2011009. 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). WE RECEIVED ONE USED, EMPTY EASYPUMP II LT 270-54-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED ON THE SAMPLE AND THE PATIENT CONNECTOR WAS OPENED (THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER). FURTHER ON, WE DETECTED CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE) OF THE SAMPLE. AFTERWARDS THE PUMP WAS FILLED WITH NACL 0.9 % UP TO THE NOMINAL VOLUME (270 ML) AND A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). AFTER THESE 60 MINUTES LEAKAGES WERE NOT DETECTED. THE TESTED SAMPLE IS NOT WITHIN OUR SPECIFICATIONS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE STATEMENT IS AVAILABLE. REVIEWED THE DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN PROCESS AND FINAL CONTROL INSPECTION.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(4)): PUMP STOPPED INFUSION. DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29393 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15D30GE271

    Patients

    Seq Age Sex Outcome Treatment
    1