BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5396951 · Received January 28, 2016

    Report

    Report Number
    9610825-2016-00502
    Event Type
    Malfunction
    Date Received
    January 28, 2016
    Report Date
    June 28, 2016
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    MEB
    PMA / PMN Number
    K081905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 AG (MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). THE DEVICE IS CURRENTLY SHIPPING FROM FRANCE TO BBM IN GERMANY FOR INVESTIGATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE INSPECTION RESULTS ARE AVAILABLE. REVIEWED THE DHR AND THERE IS NO ABNORMALITY FOUND DURING IN-PROCESS AND AT FINAL CONTROL INSPECTION.

    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 NUMBER (B)(4). WE RECEIVED ONE USED (COMPLETELY FILLED) EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL EXAMINATION. DAMAGES OR MANUFACTURING FAULTS WERE NOT DETECTED. IN AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED. THE ORIGINAL WING CAP WAS NOT HANDED OVER BY THE CUSTOMER. FURTHER ON, WE DETECTED LIQUID AND CRYSTALLIZED DRUG RESIDUES AT THE FILLING PORT (LLI-CONE) AND AT THE PATIENT CONNECTOR (LLA-CONE) OF THE SAMPLE. IN ADDITION, A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER OPENING THE WHITE CLAMP AND WAITING FOR A WHILE THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). THEREFORE THE PUMP WAS SQUEEZED BY HAND AND THE FUNCTIONAL TEST RESPECTIVELY THE LEAK TEST WAS CARRIED OUT AGAIN. SUBSEQUENTLY THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). THE TESTED SAMPLE IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. THE SAMPLE WILL BE SENT TO THE MANUFACTURER B. BRAUN MEDICAL INDUSTRIES. STATEMENT FROM MANUFACTURER: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S-US WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION, CLAMP CLIP IS CLAMPED AND THE ORIGINAL WING CAP IS NOT OBSERVED AT THE RECEIVED PUMP. BIG TOP CAP IS OPENED AND DISCOFIX CAP IS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. NO CRYSTALLIZED RESIDUE DETECTED AT MALE LUER LOCK. CLAMP CLIP IS RELEASED. NO FLOW IS OBSERVED. COMPLAINT SAMPLE IS LEFT FOR 30 MINUTES. THE PUMP REMAINED NOT FLOWING. THE COMPLAINT SAMPLE IS BLOCKED. NO OTHER DEVIATION IS OBSERVED. ANALYSIS: COMPLAINT SAMPLE IS DISSECTED BY SECTION TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE IS DISSECTED AT A (MICROBORE TUBE, BEFORE MALE LUER LOCK). IT CAN BE CONCLUDED THAT THE COMPLAINT SAMPLE IS BLOCKED DUE TO EXCESS GLUE AT MICROBORE TUBE AND FILTER CONNECTION. CORRECTIVE MEASURES HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001387. JUSTIFICATION: JUSTIFIED. 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)): NO DIFFUSION. DRUG: 5FU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56611 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15C06GE26R

    Patients

    Seq Age Sex Outcome Treatment
    1