BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EASYPUMP® II

    MDR report key: 5341505 · Received January 4, 2016

    Report

    Report Number
    9610825-2015-00663
    Event Type
    Malfunction
    Date Received
    January 4, 2016
    Date of Event
    December 11, 2015
    Report Date
    December 14, 2015
    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 DEVICE HISTORY RECORD AND NO ABNORMALITIES FOUND DURING IN-PROCESS AND 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 A(MANUFACTURER). THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT # (B)(4). WE RECEIVED ONE USED (FILLED) EASYPUMP II LT 100-50-S WITHOUT PACKAGING. THE RECEIVED SAMPLE WAS TAKEN TO A VISUAL INSPECTION. DAMAGES WERE NOT DETECTED. AS-RECEIVED CONDITION THE WHITE CLAMP WAS CLOSED AND THE PATIENT END CONNECTOR WAS CLOSED WITH A STOPPER. 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. MOREOVER, THE SAMPLE WAS TAKEN TO A FUNCTIONAL TEST RESPECTIVELY A LEAK TEST WAS CARRIED OUT. AFTER STARTING THE PUMP (OPENING THE WHITE CLAMP) AND WAITING FOR 60 MINUTES THE PUMP DID NOT WORK (SOLUTION WAS NOT RUNNING). LEAKAGES WERE NOT DETECTED AT THE SAMPLE. THE INSPECTED SAMPLE IS NOT IN ACCORDANCE WITH OUR REQUIREMENTS. WE HAVE INFORMED OUR MANUFACTURER ACCORDINGLY. DEFINE: RECEIVED ONE PIECE OF USED, FILLED OF EASYPUMP II LT 100-50-S WITHOUT ORIGINAL PACKAGING. AS RECEIVED CONDITION CLAMP CLIP WAS CLAMPED AND THE ORIGINAL WING CAP HAS BEEN REPLACED WITH RED CLOSING CONE. BIG TOP CAP WAS OPENED AND DISCOFIX CAP WAS REMOVED. DETECTED CRYSTALLIZED RESIDUE AT FILLING PORT. FURTHER ON, DETECTED CRYSTALLIZED RESIDUE AT TRIANGLE TUBE, MICROBORE TUBE AND MALE LUER LOCK. COMPLAINT SAMPLE WAS THEN TESTED WITH FUNCTIONAL TEST. RED CLOSING CONE WAS REMOVED. NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS LEFT FOR 10 MINUTES. HOWEVER, THE PUMP REMAINED NOT WORKING. NO OTHER DEVIATION WAS OBSERVED AT THE PUMP. ANALYSIS: COMPLAINT SAMPLES WERE DISSECTED BY SECTIONS TO INVESTIGATE THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. COMPLAINT SAMPLE WAS DISSECTED AT POINT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). NO FLOW WAS OBSERVED. COMPLAINT SAMPLE WAS DISSECTED AT POINT A (MICROBORE TUBE; BEFORE MALE LUER LOCK). NO FLOW WAS OBSERVED. AS THE COMPLAINT SAMPLE WAS CONTAMINATED WITH CYTOTOXIC DRUG, SECTION A AND B WERE BROUGHT BACK TO BMI FOR DECONTAMINATION AND FURTHER INVESTIGATION. THE REST OF THE SAMPLE WAS DISPOSED AT MOUNT MIRIAM HOSPITAL. AFTER DECONTAMINATION PROCESS WAS DONE, SECTION A AND B WERE TESTED WITH LEAKAGE TEST. SECTION A (MICROBORE TUBE + MLL) WAS BLOCKED. HOWEVER, SECTION B (MICROBORE TUBE + FILTER) WAS WORKING. THEREFORE, SECTION B IS RULED OUT AS THE POSSIBLE CONTRIBUTOR OF BLOCKAGE. INVESTIGATION WAS NARROWED TO SECTION A. SECTION A WAS FURTHER DISSECTED INTO SECTION A(I) (MICROBORE TUBE + STEP DOWN TUBE) AND A(II) (STEP DOWN TUBE + GLASS TUBE). SECTION A(I) AND A(II) WERE THEN TESTED WITH LEAKAGE TEST. ECTION A(I) WAS FLOWING. SECTION A(II) WAS BLOCKED. THEREFORE, SECTION A(I) WAS RULED OUT FROM POSSIBLE CONTRIBUTOR OF BLOCKAGE. INVESTIGATION WAS NARROWED DOWN TO SECTION A(II). VISUALLY INSPECTED CROSS SECTION PROFILE OF SECTION A(II) UNDER SMART SCOPE. OBSERVED CRYSTALLIZED RESIDUE INSIDE SECTION A(II). CONCLUSION: COMPLAINT SAMPLE WAS BLOCKED BY CRYSTALLIZATION AT MALE LUER LOCK. THEREFORE, THE COMPLAINT IS CONSIDERED AS NOT JUDGEABLE. NOTE : CORRECTIVE MEASURES REGARDING BLOCKAGE DUE TO CRYSTALLIZATION HAVE BEEN INITIATED AND ARE DOCUMENTED UNDER CAPA 001475. JUSTIFICATION: NOT JUDGEABLE.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY ((B)(4)): NO INFUSION. DRUG: 5FU ACCORD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981 EASYPUMP® II ELASTOMERIC INFUSION PUMP MEB B. BRAUN MELSUNGEN AG N/A 15B28GE261

    Patients

    Seq Age Sex Outcome Treatment
    1